C Mold Mixture by Antigen Laboratories, Inc. Allergenic Extract
C Mold Mixture by
Drug Labeling and Warnings
C Mold Mixture by is a Prescription medication manufactured, distributed, or labeled by Antigen Laboratories, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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BOXED WARNING
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WARNINGS
Allergenic extract is intended for use by, or under the guidance of, physicians who are experienced in the administration of allergenic extracts for diagnosis and/or immunotherapy and the emergency care of anaphylaxis. This extract is not directly interchangeable with other allergenic extracts. The initial dose must be based on skin testing as described in the “DOSAGE AND ADMINISTRATION” section of this insert. Patients switching from other types of extracts to Antigen Laboratories’ allergenic extracts should be started as if they were undergoing treatment for the first time. Patients being switched from one lot of extract to another from the same manufacturer should have the dose reduced by 75%.
Severe systemic reactions may occur with all allergenic extracts. In certain individuals, especially in steroid-dependent/unstable asthmatics, these life-threatening reactions may result in death. Patients should be observed for at least 20 minutes following allergenic extract injections. Treatment and emergency measures, as well as personnel trained in their use, must be available in the event of a life-threatening reaction. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. Report serious adverse events to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, phone 1-800-FDA-1088.
This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. See the “WARNINGS”, “PRECAUTIONS”, “ADVERSE REACTIONS” and “OVERDOSAGE” sections.
Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously. Refer to “WARNINGS”, “PRECAUTIONS” and “ADVERSE REACTIONS” sections below.
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DESCRIPTION
Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin.
FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:
Sodium chloride…………………………………………………………….0.95%
Sodium bicarbonate………………………………………………………..0.24%
Glycerine…………………………………………………………………50% (v/v)
Water for Injection…………………………………………………q.s. to volume
Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular.
Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v).
Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.
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CLINICAL PHARMACOLOGY
Studies indicate allergic individuals produce immunoglobulins of the IgE class in response to exposure to allergens. Subsequent exposure to the allergen results in a combination of allergen with IgE antibody fixed on mast cells or basophil membranes. This cross-linking results in stimulation of mast cell which leads to release and generation of pharmacologically active substances that produce immediate hypersensitivity reaction.3
The mode of action of immunotherapy with allergenic extracts is still under investigation. Subcutaneous injections of increasing doses of allergenic extract into patients with allergic disease have been shown to result in both humoral and cellular changes including the production of allergen-specific IgG antibodies, the suppression of histamine release from target cells, decrease in circulating levels of antigen specific IgE antibody over long periods of time and suppression of peripheral blood T-lymphocyte cell responses to antigen.10, 14, 15
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INDICATIONS AND USAGE
Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.
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CONTRAINDICATIONS
Do not administer in the presence of diseases characterized by bleeding diathesis. Individuals with autoimmune disease may be at risk of exacerbating symptoms of the underlying disease, possibly due to routine immunization. Patients who have experienced a recent myocardial infarction may not be tolerant of immunotherapy. Children with nephrotic syndrome probably should not receive injections due to immunization causing exacerbation of nephrotic disease.
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WARNINGS
Refer to boxed “WARNINGS”, “PRECAUTIONS”, “ADVERSE REACTIONS” and “OVERDOSAGE” sections for additional information on serious adverse reactions and steps to be taken, if any occur.
Extreme caution is necessary when using diagnostic skin tests or injection treatment in highly sensitive patients who have experienced severe symptoms or anaphylaxis by natural exposure, or during previous skin testing or treatment. IN THESE CASES THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENT’S SENSITIVITY AND TOLERANCE.
Benefit versus risk needs to be evaluated in steroid dependent asthmatics, patients with unstable asthma or patients with underlying cardiovascular disease.
Injections should never be given intravenously. A 5/8 inch, 25 gauge needle on a sterile syringe allows deep subcutaneous injection. Withdraw plunger slightly after inserting needle to determine if a blood vessel has been entered.
Proper measurement of dose and caution in making injection will minimize reactions. Adverse reactions to allergenic extracts are usually apparent within 20-30 minutes following injection of immunotherapy.
Extract should be temporarily withheld or dosage reduced in case of any of the following conditions: 1) flu or other infection with fever; 2) exposure to excessive amounts of allergen prior to injection; 3) rhinitis and/or asthma exhibiting severe symptoms; 4) adverse reaction to previous injection until cause of reaction has been evaluated by physician supervising patient’s immunotherapy program.
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PRECAUTIONS
Immunotherapy must be given under physician’s supervision. Sterile solutions, vials, syringes, etc. must be used. Aseptic technique must be observed in making dilutions from stock concentrates. The usual precautions in administering allergenic extracts are necessary, refer to boxed WARNINGS and “WARNINGS” section. Sterile syringe and needle must be used for each individual patient to prevent transmission of serum hepatitis, Human Immunodeficiency Virus (HIV) and other infectious agents.
Epinephrine 1:1000 should be available. Refer to “OVERDOSAGE” section for description of treatment for anaphylactic reactions.
Patient should remain under observation of a nurse, physician, or personnel trained in emergency measures for at least 20 minutes following immunotherapy injection. Patient must be instructed to report any adverse reactions that occur within 24 hours after injection. Possible adverse reactions include unusual swelling and/or tenderness at injection site, rhinorrhea, sneezing, coughing, wheezing, shortness of breath, nausea, dizziness, or faintness. Immediate medical attention must be sought for reactions that occur during or after leaving physician’s office.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long term studies in animals have not been conducted with allergenic extract to determine their potential for carcinogenicity, mutagenicity or impairment of fertility.
Animal reproduction studies have not been conducted with allergenic extracts. It is not known whether allergenic extracts cause fetal harm during pregnancy or affect reproductive capacity. A systemic reaction to allergenic extract could cause uterine contractions leading to spontaneous abortion or premature labor. Allergenic extracts should be used during pregnancy only if potential benefit justifies potential risk to fetus.11
It is not known whether allergenic extracts are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.
Allergenic extracts have been used routinely in children, and no special safety problems or specific hazards have been found. Children can receive the same dose as adults. Discomfort is minimized by dividing the dose in half and administering injection at two different sites.16, 17
Antihistamines. Antihistamines inhibit the wheal and flare reaction. The inhibitory effect of conventional antihistamines varies from 1 day up to 10 days, according to the drug and patient’s sensitivity. Long acting antihistamines (e.g., astemizole) may inhibit the wheal and flare for up to forty days.1, 2
Imipramines, phenothiazines, and tranquilizers. Tricyclic antidepressants exert a potent and sustained decrease of skin reactions to histamine. This effect may last for a few weeks. Tranquilizers and antiemetic agents of the phenothiazine class have H1 antihistaminic activity and can block skin tests.1
Corticosteroids. Short-term (less than 1 week) administration of corticosteroids at the therapeutic doses used in asthmatic patients does not modify the cutaneous reactivity to histamine, compound 48/80, or allergen. Long-term corticosteroid therapy modifies the skin texture and makes the interpretation of immediate skin tests more difficult.1
Theophylline. It appears that theophylline need not be stopped prior to skin testing.1
Beta-Blockers. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. The following are commonly prescribed beta-blockers: Levatol, Lopressor, Propanolol Intersol, Propanolol HCL, Blocadren, Propanolol, Inderal-LA, Visken, Corgard, Ipran, Tenormin, Timoptic. Ophthalmic beta-blockers: Betaxolol, Levobunolol, Timolol, Timoptic. Chemicals that are beta-blockers and may be components of other drugs: Acebutolol, Atenolol, Esmolol, Metoprolol, Nadolol, Penbutolol, Pindolol, Propanolol, Timolol, Labetalol, Carteolol.1
Beta-adrenergic agents. Inhaled beta2 agonists in the usual doses used for the treatment of asthma do not usually inhibit allergen-induced skin tests. However, oral terbutaline and parenteral ephedrine were shown to decrease the allergen-induced wheal.1
Cromolyn. Cromolyn inhaled or injected prior to skin tests with allergens or degranulating agents does not alter skin whealing response.1
Other drugs. Other drugs have been shown to decrease skin test reactivity. Among them, dopamine is the best-documented compound.1
Specific Immunotherapy. A decreased skin test reactivity has been observed in patients undergoing specific immunotherapy with pollen extracts, grass pollen allergoids, mites, hymenoptera venoms, or in professional beekeepers who are spontaneously desensitized. Finally, it was shown that specific immunotherapy in patients treated with ragweed pollen extract induced a decreased late-phase reaction.1
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ADVERSE REACTIONS
Adverse reactions include, but are not limited to urticaria; itching; edema of extremities; respiratory wheezing or asthma; dyspnea; cyanosis; tachycardia; lacrimation; marked perspiration; flushing of face, neck or upper chest; mild persistent clearing of throat; hacking cough or persistent sneezing.
A mild burning immediately after injection is expected; this usually subsides in 10-20 seconds. Prolonged pain or pain radiating up arm is usually the result of intramuscular injection, making this injection route undesirable. Subcutaneous injection is the recommended route.
Small amounts of erythema and swelling at the site of injection are common. Reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm in diameter.
Larger local reactions are not only uncomfortable, but indicate the possibility of a severe systemic reaction if dosage is increased. In such cases dosage should be reduced to the last level not causing reaction and maintained for two or three treatments before cautiously increasing.
Large, persistent local reactions or minor exacerbations of the patient’s allergic symptoms may be treated by local cold applications and/or use of oral antihistamines.
Systemic reactions range from mild exaggeration of patient’s allergic symptoms to anaphylactic reactions.14 Very sensitive patients may show a rapid response. It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. Fatalities are rare but can occur.5 Other possible systemic reaction symptoms are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis,and urticaria.13, 14
Careful attention to dosage and administration limit such reactions. Allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and prepare for treatment of severe reactions. Refer to “OVERDOSAGE” section.
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OVERDOSAGE
Refer to “WARNINGS”, “PRECAUTIONS” and “ADVERSE REACTIONS” sections for signs and symptoms of an overdose.
If a systemic or anaphylactic reaction does occur, apply tourniquet above the site of allergenic extract injection and inject intramuscularly or subcutaneously 0.3 to 0.5 ml of 1:1000 Epinephrine-hydrochloride into the opposite arm or gluteal area. Repeat dose in 5-10 minutes if necessary. Loosen tourniquet briefly at 5 minute intervals to prevent circulatory impairment. Discontinue use of the tourniquet after ½ hour.
The epinephrine HCL 1:1000 dose for infants to 2 years is 0.05 to 0.1 ml; for children 2 to 6 years it is 0.15 ml; for children 6 to 12 years it is 0.2 ml.
Symptoms of progressive anaphylaxis include airway obstruction and/or vascular collapse. After administration of epinephrine, profound shock and vasomotor collapse should be treated with intravenous fluids and possibly vasoactive drugs. Monitor airways for obstruction. Oxygen should be given by mask if indicated.
Antihistamines, H2 antagonist, bronchodilators, steroids and theophylline may be used as indicated after providing adequate epinephrine and circulatory support.4
Patients who have been taking beta-blockers may be unresponsive to epinephrine. Epinephrine or beta-adrenergic drugs (Alupent) may be ineffective. These drugs should be administered even though a beta-blocker may have been taken. The following treatment will be effective whether or not patient is taking a beta-blocker: Aminophylline IV, slow push or drip, Atrovent (Ipratropium bromide) Inhaler, 3 inhalations repeated, Atropine, 0.4 mg/ml, 0.75 to 1.5 ml IM or IV, Solu-Cortef, 100-200 mg IM or IV, Solu-Medrol, 125 mg IM or IV, Glucagon, 0.5-1 mg IM or IV, Benadryl, 50 mg IM or IV, Cimetidine, 300 mg IM or IV, Oxygen via ambu bag.
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DOSAGE AND ADMINISTRATION
Refer to “STORAGE” section for proper storage condition for allergenic extract. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Some allergenic extracts naturally precipitate.
Physicians undertaking immunotherapy should be concerned with patient’s degree of sensitivity. The initial dilution of allergenic extract, starting dose, and progression of dosage must be carefully determined on the basis of the patient’s history and results of skin tests. Strongly positive skin tests may be risk factors for systemic reactions. Less aggressive immunotherapy schedules may be indicated for such patients.
Precaution is necessary when using extract mixture for skin testing. The diluting effect of individual components within a mixture may cause false negative reactions. Patients extremely sensitive to a common allergen in several components of a mixture may be more likely to experience a systemic reaction than when skin tested individually for each component.9
PRICK-PUNCTURE TESTING: To identify highly sensitive individuals and as a safety precaution, it is recommended that a prick-puncture test using a drop of the extract concentrate be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. A positive reaction is approximately 10-15 mm erythema with 2.5 mm wheal. Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intradermally with an appropriately diluted extract.
A positive control using histamine phosphate identifies patients whose skin may not react due to medications, metabolic or other reasons. A negative control (50% glycerine for prick-puncture testing) would exclude false-positive reactions due to ingredients in diluent or patients who have dermatographism.
SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions, five-fold or ten-fold, may be prepared from stock concentrate using physiologic saline as a diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, or a negative or weakly reactive prick-puncture test, the initial dilution for skin testing should be a dilution at least 1:12,500 w/v. This initial dilution can be prepared by diluting 1:20 to 1:50 w/v (2%-5%) extracts five-fold to 5-4 or 1:10 w/v (10%) extracts to 5-5. See “Serial Dilutions Titration Test Dilutions” chart on the next page. Dilute 1:10 w/v (10%) extracts to 10-3 if using ten-fold dilutions. (4) Sensitive patients with a positive prick-puncture test require a further dilution to at least 1:312,500 w/v. This dilution can be prepared by diluting 1:20 to 1:50 w/v (2% - 5%) extracts to 5-6 or 1:10 w/v (10%) extracts to 5-7 (five-fold dilutions). Ten-fold dilution to 10-6 of a 1:10 w/v (10%) extract would be a safe starting dilution. Size of reactions are quantitated based on size of wheal and erythema. For interpretation of skin reactions, refer to chart below. If after 20 minutes no skin reaction is observed, continue testing using increasing increments of the concentration until a reaction of 5-10 mm wheal and 11-30 mm erythema is obtained, or a concentration of 5-2 or 10-1 has been tested. A negative control, 50% glycerine diluted with diluent to 5-2 (1:25) or 10-1 (1:10) dilution and a positive control of histamine phosphate, should be tested and included in interpretation of skin reactions.1, 13
GRADE mm ERYTHEMA mm WHEAL 0 less than 5 less than 5 ± 5-10 5-10 1+ 11-20 5-10 2+ 21-30 5-10 3+ 31-40 10-15 or with pseudopods 4+ greater than 40 greater than 15 or with many pseudopods INTRADERMAL TESTING-SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient’s degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving progressive five-fold dilutions of allergenic extracts. Intracutaneously inject 0.01 to 0.02 ml of the test allergen to form a 4 mm diameter superficial skin wheal. For patients demonstrating a negative or weakly reactive prick-puncture skin test, an initial screening dilution of 1:12,500 w/v is safe. For patients demonstrating a positive prick-puncture skin test, an initial screening dilution of 1:312,500 w/v is safe. (See “Serial Dilution Titration Test Dilutions” chart below.) When a sequence of five-fold or ten-fold dilutions of an allergen are injected, the endpoint is determined by noting the dilution that first produces a wheal and erythema (15 minutes after injection) that is 2 mm larger than wheals with erythema produced by weaker, non-reacting dilutions (5 mm negative wheal). The endpoint dilution is used as a starting dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each individual.
Injections should never be given intravenously. A 5/8 inch, 25 gauge needle on a sterile syringe will allow deep subcutaneous injection.
IMMUNOTHERAPY: If the first injection of the initial dilution of extract is tolerated without significant local reaction, increasing doses by 5-20% increments of that dilution may be administered. The rate of increase in dosage in the early stages of treatment with highly diluted extracts is usually more rapid than the rate of increase possible with more concentrated extracts. This schedule is intended only as a guide and must be modified according to the reactivity of the individual patient. Needless to say, the physician must proceed cautiously in the treatment of the highly sensitive patient who develops large local or systemic reactions.6
Some patients may tolerate larger doses of the allergenic extract depending on patient response.7 Because diluted extract tends to lose activity in storage, the first dose from a more concentrated vial should be the same, or less than, the previous dose.8, 12
Dosages progressively increase according to the tolerance of the patient at intervals of one to seven days until, (1) the patient achieves relief from symptoms, (2) induration at the site of injection is no larger than 50 mm in 36 to 48 hours, (3) a maintenance dose is reached (the largest dose tolerated by the patient that relieves symptoms without undesirable local or systemic reactions). This maintenance dose may be continued at regular intervals perennially. It may be necessary to adjust the progression of dosage downward to avoid local and constitutional reactions.
The usual duration of treatment has not been established. A period of two or three years on immunotherapy constitutes an average minimum course of treatment.
SERIAL DILUTION TITRATION TEST DILUTIONS APPROXIMATE ALLERGENIC EXTRACT CONCENTRATION RESULTING FROM 1:5 DILUTION Titration Number Dilution Exponent Weight / Volume Allergenic Extract Concentrate 1:50 (2%) 1:40 (2 1/2%) 1:33 1/3 (3%) 1:20 (5%) 1:10 (10%) No. 1 5-1 1:5 1:250 1:200 1:167 1:100 1:50 No. 2 5-2 1:25 1:1,250 1:1,000 1:835 1:500 1:250 No. 3 5-3 1:125 1:6,250 1:5,000 1:4,175 1:2,500 1:1,250 No. 4 5-4 1:625 1:31,250 1:25,000 1:20,875 1:12,500 1:6,250 No. 5 5-5 1:3,125 1:156,250 1:125,000 1:104,375 1:62,500 1:31,250 No. 6 5-6 1:15,625 1:781,250 1:625,000 1:521,875 1:312,500 1:156,250 No. 7 5-7 1:78,125 1:3,906,250 1:3,125,000 1:2,609,375 1:1,562,500 1:781,250 No. 8 5-8 1:390,625 1:19,531,250 1:15,625,000 1:13,046,875 1:7,812,500 1:3,906,250 No. 9 5-9 1:1,953,125 1:97,656,250 1:78,125,000 1:65,234,375 1:39,062,500 1:19,531,250 No. 10 5-10 1:9,765,625 1:488,281,250 1:390,625,000 1:326,171,875 1:195,312,500 1:97,656,250 No. 11 5-11 1:48,828,125 1:2,441,406,250 1:1,953,125,000 1:1,630,859,375 1:976,562,500 1:488,281,250 No. 12 5-12 1:244,140,625 1:12,207,031,250 1:9,765,625,000 1:8,154,296,875 1:4,882,812,500 1:2,441,406,250 -
HOW SUPPLIED
Stock concentrates are available in concentrations of 2-10% or weight/volume (w/v) of 1:50, 1:33, 1:20 or 1:10. Some juicy or liquid foods are available at 1:1 volume/volume (v/v) extraction ratio. Fresh egg white extract is available at 1:9 v/v extraction ratio.
Antigen E content of ragweed mixtures ranges from 46-166 U/ml for Ragweed Mixture (Short/Giant/Western/Southern Ragweed), 47-239 U/ml for Short/Giant/Western Ragweed Mixture, and 106-256 U/ml for Short/Giant Ragweed Mixture. Refer to container label for actual Antigen E content.
Extract (stock concentrate) is supplied in 10, 30 and 50 ml containers. Extracts in 5 ml dropper bottles are available for prick-puncture testing. To insure maximum potency for the entire dating period, all stock concentrates contain 50% glycerine v/v.
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STORAGE
Store all stock concentrates and dilutions at 2-8° C. Keep at this temperature during office use. The expiration date of the allergenic extracts is listed on the container label. Dilutions of the allergenic extracts containing less than 50% glycerine are less stable. If loss of potency is suspected, potency can be checked using side by side skin testing with freshly prepared dilutions of equal concentration on individuals with known sensitivity to the allergen.
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REFERENCES
1. Bousquet, Jean: “In vivo methods for study of allergy: Skin tests” Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. I, Chap. 19, pp 419-436, 1988.
2. Long, W.F., Taylor, R.J., Wagner, C.J., et al.: Skin test suppression by antihistamines and the development of subsensitivity, J. Allergy Clin. Immunol., pp. 76-113, 1985.
3. Holgate, S.T., Robinson, C., Church, Mike: Mediators of Immediate Hypersensitivity, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. I and II, pp 135-163, 1988.
4. Wasserman, S., Marquart, D.: Anaphylaxis, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. 1, Chap. 58, pp. 1365-1376, 1988.
5. Reid, Michael J., Lockey, Richard F., Turkeltaub M.D., Paul C., Platts-Mills, Thomas. “Survey of Fatalities from Skin Testing and Immunotherapy 1985-1989”, Journal of Allergy and Clinical Immunology, Vol. 92, No. 1, pp. 6-15, 1993.
6. Matthews, K., et al: Rhinitis, Asthma and Other Allergic Diseases. NIAID Task Force Report, U.S. Dept. HEW, NIH Publication No. 79-387, Chapter 4, pp. 213-217, May 1979.
7. Ishizaka, K.: Control of IgE Synthesis, Third Edition, Allergy Principles and Practices, Vol. I, Chap. 4, p. 52, edited by Middleton et al.
8. Nelson, H.S.: “The Effect of Preservatives and Dilution on the Deterioration of Russian Thistle (Salsola pestifer), a pollen extract.” The Journal of Allergy and Clinical Immunology, Vol. 63, No. 6, pp. 417-425, June 1979.
9. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp. 84-86.
10. Rocklin, R.E., Sheffer, A.L., Grainader, D.K. and Melmon, K.: “Generation of antigen-specific suppressor cells during allergy desensitization”, New England Journal of Medicine, 302, May 29, 1980, pp. 1213-1219.
11. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp 9-48.
12. Stevens, E.: Cutaneous Tests, Regulatory Control and Standardization of Allergenic Extracts, First International Paul-Ehrlich Seminar, May 20-22, 1979, Frankfurt, Germany, pp. 133-138.
13. Van Metre, T., Adkinson, N., Amodio, F., Lichtenstein, L., Mardinay, M., Norman, P., Rosenberg, G., Sobotka, A., Valentine, M.: “A Comparative Study of the Effectiveness of the Rinkel Method and the Current Standard Method of Immunology for Ragweed Pollen Hay Fever,“ The Journal of Clinical Allergy and Immunology, Vol. 66, No. 6, p. 511, December 1980.
14. Wasserman, S.: The Mast Cell and the Inflammatory Response. The Mast Cell-its role in Health and disease. Edited by J. Pepys & A.M. Edwards, Proceedings of an International Symposium, Davos, Switzerland, Pitman Medical Publishing Co., 1979, pp. 9-20.
15. Perelmutter, L.: IgE Regulation During Immunotherapy of Allergic Diseases. Annals of Allergy, Vol. 57, August 1986.
16. Bullock, J., Frick, O.: Mite Sensitivity in House Dust Allergic Children, Am. J. Dis. Child., pp. 123-222, 1972.
17. Willoughby, J.W.: Inhalant Allergy Immunotherapy with Standardized and Nonstandardized Allergenic Extracts, American Academy of Otolaryngology-Head and Neck Surgery: Instructional Courses, Vol. 1, Chapter 15, C.V. Mosby Co., St. Louis, Missouri, September 1988.
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INGREDIENTS AND APPEARANCE
CHAETOMIUM
chaetomium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0094 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0094-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0094-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0094-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0094-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0094-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 CEPHALOSPORIUM
cephalosporium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0089 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACREMONIUM STRICTUM (UNII: 3F36V0451W) (ACREMONIUM STRICTUM - UNII:3F36V0451W) ACREMONIUM STRICTUM 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0089-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0089-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0089-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0089-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0089-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 CLADOSPORIUM HERBARUM
cladosporium herbarum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0159 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM HERBARUM (UNII: O64JF11198) (CLADOSPORIUM HERBARUM - UNII:O64JF11198) CLADOSPORIUM HERBARUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0159-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0159-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0159-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0159-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0159-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 CURVULARIA
curvularia injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0098 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SPICIFER (UNII: 91M9RWP3TD) (COCHLIOBOLUS SPICIFER - UNII:91M9RWP3TD) COCHLIOBOLUS SPICIFER 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0098-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0098-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0098-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0098-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0098-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 BOTRYTIS
botrytis injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0039 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0039-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0039-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0039-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0039-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0039-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 ASPERGILLUS NIGER
aspergillus niger injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0033 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0033-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0033-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0033-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0033-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0033-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/23/1974 CEPHALOSPORIUM
cephalosporium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0088 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACREMONIUM STRICTUM (UNII: 3F36V0451W) (ACREMONIUM STRICTUM - UNII:3F36V0451W) ACREMONIUM STRICTUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0088-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0088-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0088-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0088-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0088-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 BERMUDA GRASS SMUT
bermuda grass smut injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0065 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO CYNODONTIS (UNII: 0V3J4YEX2W) (USTILAGO CYNODONTIS - UNII:0V3J4YEX2W) USTILAGO CYNODONTIS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0065-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0065-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0065-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0065-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0065-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 HELMINTHOSPORIUM
helminthosporium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0249 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0249-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0249-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0249-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0249-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0249-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 HELMINTHOSPORIUM
helminthosporium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0248 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0248-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0248-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0248-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0248-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0248-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 JOHNSON GRASS SMUT
johnson grass smut injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0280 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 0.02 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0280-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0280-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0280-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0280-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0280-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 JOHNSON GRASS SMUT
johnson grass smut injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0279 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0279-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0279-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0279-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0279-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0279-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 FUSARIUM OXYSPORUM
fusarium oxysporum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0198 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM (UNII: 5398RXP8KU) (FUSARIUM OXYSPORUM - UNII:5398RXP8KU) FUSARIUM OXYSPORUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0198-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0198-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0198-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0198-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0198-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 EPICOCCUM
epicoccum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0187 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0187-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0187-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0187-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0187-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0187-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 HORMODENDRUM
hormodendrum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0246 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0246-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0246-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0246-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0246-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0246-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 HORMODENDRUM
hormodendrum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0245 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0245-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0245-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0245-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0245-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0245-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 NUMBER FOUR MOLD MIXTURE
number four mold mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0210 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.0125 g in 1 mL ASPERGILLUS FLAVUS (UNII: 3J888Y9L13) (ASPERGILLUS FLAVUS - UNII:3J888Y9L13) ASPERGILLUS FLAVUS 0.0031 g in 1 mL ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.0031 g in 1 mL ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.0031 g in 1 mL ASPERGILLUS REPENS (UNII: SQ89E6LOME) (ASPERGILLUS REPENS - UNII:SQ89E6LOME) ASPERGILLUS REPENS 0.0031 g in 1 mL CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.0125 g in 1 mL PENICILLIUM CAMEMBERTI (UNII: T069R9OPVG) (PENICILLIUM CAMEMBERTI - UNII:T069R9OPVG) PENICILLIUM CAMEMBERTI 0.0021 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0021 g in 1 mL PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z) PENICILLIUM EXPANSUM 0.0021 g in 1 mL PENICILLIUM ITALICUM (UNII: AZJ5XKM7W3) (PENICILLIUM ITALICUM - UNII:AZJ5XKM7W3) PENICILLIUM ITALICUM 0.0021 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0021 g in 1 mL PENICILLIUM ROQUEFORTI (UNII: 7ORP6R724L) (PENICILLIUM ROQUEFORTI - UNII:7ORP6R724L) PENICILLIUM ROQUEFORTI 0.0021 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0210-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0210-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0210-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0210-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0210-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 GRASS SMUT MIXTURE
grass smut mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0214 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO CYNODONTIS (UNII: 0V3J4YEX2W) (USTILAGO CYNODONTIS - UNII:0V3J4YEX2W) USTILAGO CYNODONTIS 0.05 g in 1 mL SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0214-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0214-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0214-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0214-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0214-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 GRAIN SMUT MIXTURE
grain smut mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0211 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO NUDA HORDEI (UNII: 9Y53ZS6I82) (USTILAGO NUDA HORDEI - UNII:9Y53ZS6I82) USTILAGO NUDA HORDEI 0.025 g in 1 mL USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.025 g in 1 mL USTILAGO AVENAE (UNII: YIH315U1TU) (USTILAGO AVENAE - UNII:YIH315U1TU) USTILAGO AVENAE 0.025 g in 1 mL USTILAGO TRITICI (UNII: BV82OL2IZ8) (USTILAGO TRITICI - UNII:BV82OL2IZ8) USTILAGO TRITICI 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0211-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0211-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0211-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0211-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0211-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 A MOLD MIXTURE
a mold mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0004 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FLAVUS (UNII: 3J888Y9L13) (ASPERGILLUS FLAVUS - UNII:3J888Y9L13) ASPERGILLUS FLAVUS 0.0017 g in 1 mL ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.0017 g in 1 mL ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.0017 g in 1 mL ASPERGILLUS REPENS (UNII: SQ89E6LOME) (ASPERGILLUS REPENS - UNII:SQ89E6LOME) ASPERGILLUS REPENS 0.0017 g in 1 mL BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 0.0067 g in 1 mL CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 0.0067 g in 1 mL EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.0067 g in 1 mL FUSARIUM OXYSPORUM (UNII: 5398RXP8KU) (FUSARIUM OXYSPORUM - UNII:5398RXP8KU) FUSARIUM OXYSPORUM 0.0067 g in 1 mL GEOTRICHUM CANDIDUM (UNII: 5964J742O8) (GEOTRICHUM CANDIDUM - UNII:5964J742O8) GEOTRICHUM CANDIDUM 0.0067 g in 1 mL COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.0067 g in 1 mL CANDIDA TROPICALIS (UNII: Q222J2186W) (CANDIDA TROPICALIS - UNII:Q222J2186W) CANDIDA TROPICALIS 0.0033 g in 1 mL NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 0.0033 g in 1 mL MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 0.0022 g in 1 mL MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.0022 g in 1 mL PENICILLIUM CAMEMBERTI (UNII: T069R9OPVG) (PENICILLIUM CAMEMBERTI - UNII:T069R9OPVG) PENICILLIUM CAMEMBERTI 0.0011 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0011 g in 1 mL PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z) PENICILLIUM EXPANSUM 0.0011 g in 1 mL PENICILLIUM ITALICUM (UNII: AZJ5XKM7W3) (PENICILLIUM ITALICUM - UNII:AZJ5XKM7W3) PENICILLIUM ITALICUM 0.0011 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0011 g in 1 mL PENICILLIUM ROQUEFORTI (UNII: 7ORP6R724L) (PENICILLIUM ROQUEFORTI - UNII:7ORP6R724L) PENICILLIUM ROQUEFORTI 0.0011 g in 1 mL PHOMA DESTRUCTIVA (UNII: A17SE577FM) (PHOMA DESTRUCTIVA - UNII:A17SE577FM) PHOMA DESTRUCTIVA 0.0067 g in 1 mL AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.0067 g in 1 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.0067 g in 1 mL RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 0.0067 g in 1 mL SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE 0.0067 g in 1 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.0022 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0004-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0004-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0004-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0004-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0004-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 MICROSPORUM CANIS
microsporum canis injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0299 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICROSPORUM CANIS (UNII: N4F4RQ7BY7) (MICROSPORUM CANIS - UNII:N4F4RQ7BY7) MICROSPORUM CANIS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0299-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0299-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0299-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0299-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0299-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 B MOLD MIXTURE
b mold mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0035 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOTHECIUM ROSEUM (UNII: TGO054E31O) (TRICHOTHECIUM ROSEUM - UNII:TGO054E31O) TRICHOTHECIUM ROSEUM 0.0071 g in 1 mL PASSALORA FULVA (UNII: HR6H5057CO) (PASSALORA FULVA - UNII:HR6H5057CO) PASSALORA FULVA 0.0071 g in 1 mL COCHLIOBOLUS SPICIFER (UNII: 91M9RWP3TD) (COCHLIOBOLUS SPICIFER - UNII:91M9RWP3TD) COCHLIOBOLUS SPICIFER 0.0071 g in 1 mL MYROTHECIUM VERRUCARIA (UNII: W5U19AK212) (MYROTHECIUM VERRUCARIA - UNII:W5U19AK212) MYROTHECIUM VERRUCARIA 0.0071 g in 1 mL HYPOMYCES PERNICIOSUS (UNII: 6K41G30A6U) (HYPOMYCES PERNICIOSUS - UNII:6K41G30A6U) HYPOMYCES PERNICIOSUS 0.0071 g in 1 mL NEUROSPORA CRASSA (UNII: 1X92VM01YP) (NEUROSPORA CRASSA - UNII:1X92VM01YP) NEUROSPORA CRASSA 0.0071 g in 1 mL KHUSKIA ORYZAE (UNII: VK8C112WTS) (KHUSKIA ORYZAE - UNII:VK8C112WTS) KHUSKIA ORYZAE 0.0071 g in 1 mL PAECILOMYCES VARIOTII (UNII: KO7V58BY40) (PAECILOMYCES VARIOTII - UNII:KO7V58BY40) PAECILOMYCES VARIOTII 0.0071 g in 1 mL MICROASCUS BREVICAULIS (UNII: DHI513VXU7) (MICROASCUS BREVICAULIS - UNII:DHI513VXU7) MICROASCUS BREVICAULIS 0.0071 g in 1 mL COLLETOTRICHUM COCCODES (UNII: Y0M7LGE3Z8) (COLLETOTRICHUM COCCODES - UNII:Y0M7LGE3Z8) COLLETOTRICHUM COCCODES 0.0071 g in 1 mL PLEOSPORA HERBARUM (UNII: 0N3Z1P4B2W) (PLEOSPORA HERBARUM - UNII:0N3Z1P4B2W) PLEOSPORA HERBARUM 0.0071 g in 1 mL STREPTOMYCES GRISEUS (UNII: G0O5980Z7W) (STREPTOMYCES GRISEUS - UNII:G0O5980Z7W) STREPTOMYCES GRISEUS 0.0071 g in 1 mL TRICHODERMA VIRIDE (UNII: T8678F0P0Q) (TRICHODERMA VIRIDE - UNII:T8678F0P0Q) TRICHODERMA VIRIDE 0.0071 g in 1 mL TRICHOPHYTON SCHOENLEINII (UNII: Z4MD1809H1) (TRICHOPHYTON SCHOENLEINII - UNII:Z4MD1809H1) TRICHOPHYTON SCHOENLEINII 0.0071 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 g in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0035-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0035-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0035-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0035-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0035-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 ASPERGILLUS MIXTURE
aspergillus mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0007 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FLAVUS (UNII: 3J888Y9L13) (ASPERGILLUS FLAVUS - UNII:3J888Y9L13) ASPERGILLUS FLAVUS 0.0025 g in 1 mL ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.0025 g in 1 mL ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.0025 g in 1 mL ASPERGILLUS REPENS (UNII: SQ89E6LOME) (ASPERGILLUS REPENS - UNII:SQ89E6LOME) ASPERGILLUS REPENS 0.0025 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0007-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0007-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0007-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0007-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0007-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 ALTERNARIA ALTERNATA
alternaria alternata injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0002 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0002-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0002-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0002-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0002-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0002-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 NUMBER TEN MOLD MIXTURE
number ten mold mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0586 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.01 g in 1 mL ASPERGILLUS FLAVUS (UNII: 3J888Y9L13) (ASPERGILLUS FLAVUS - UNII:3J888Y9L13) ASPERGILLUS FLAVUS 0.0025 g in 1 mL ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.0025 g in 1 mL ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.0025 g in 1 mL ASPERGILLUS REPENS (UNII: SQ89E6LOME) (ASPERGILLUS REPENS - UNII:SQ89E6LOME) ASPERGILLUS REPENS 0.0025 g in 1 mL FUSARIUM OXYSPORUM (UNII: 5398RXP8KU) (FUSARIUM OXYSPORUM - UNII:5398RXP8KU) FUSARIUM OXYSPORUM 0.01 g in 1 mL COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.01 g in 1 mL CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.01 g in 1 mL MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.01 g in 1 mL PENICILLIUM CAMEMBERTI (UNII: T069R9OPVG) (PENICILLIUM CAMEMBERTI - UNII:T069R9OPVG) PENICILLIUM CAMEMBERTI 0.0017 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0017 g in 1 mL PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z) PENICILLIUM EXPANSUM 0.0017 g in 1 mL PENICILLIUM ITALICUM (UNII: AZJ5XKM7W3) (PENICILLIUM ITALICUM - UNII:AZJ5XKM7W3) PENICILLIUM ITALICUM 0.0017 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0017 g in 1 mL PENICILLIUM ROQUEFORTI (UNII: 7ORP6R724L) (PENICILLIUM ROQUEFORTI - UNII:7ORP6R724L) PENICILLIUM ROQUEFORTI 0.0017 g in 1 mL PHOMA DESTRUCTIVA (UNII: A17SE577FM) (PHOMA DESTRUCTIVA - UNII:A17SE577FM) PHOMA DESTRUCTIVA 0.01 g in 1 mL AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.01 g in 1 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.01 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0586-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0586-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0586-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0586-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0586-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0031 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0031-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0031-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0031-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0031-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0031-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 ALTERNARIA ALTERNATA
alternaria alternata injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0003 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0003-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0003-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0003-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0003-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0003-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 MUCOR MIXTURE
mucor mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0294 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 0.0333 g in 1 mL MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.0333 g in 1 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.0333 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0294-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0294-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0294-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0294-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0294-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 MONILIA MIXTURE
monilia mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0293 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA TROPICALIS (UNII: Q222J2186W) (CANDIDA TROPICALIS - UNII:Q222J2186W) CANDIDA TROPICALIS 0.025 g in 1 mL NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0293-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0293-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0293-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0293-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0293-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 TRICHOPHYTON MIXTURE
trichophyton mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0576 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 0.05 g in 1 mL TRICHOPHYTON RUBRUM (UNII: 2ZAU32517N) (TRICHOPHYTON RUBRUM - UNII:2ZAU32517N) TRICHOPHYTON RUBRUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0576-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0576-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0576-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0576-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0576-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 PENICILLIUM MIXTURE
penicillium mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0363 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CAMEMBERTI (UNII: T069R9OPVG) (PENICILLIUM CAMEMBERTI - UNII:T069R9OPVG) PENICILLIUM CAMEMBERTI 0.0167 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0167 g in 1 mL PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z) PENICILLIUM EXPANSUM 0.0167 g in 1 mL PENICILLIUM ITALICUM (UNII: AZJ5XKM7W3) (PENICILLIUM ITALICUM - UNII:AZJ5XKM7W3) PENICILLIUM ITALICUM 0.0167 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0167 g in 1 mL PENICILLIUM ROQUEFORTI (UNII: 7ORP6R724L) (PENICILLIUM ROQUEFORTI - UNII:7ORP6R724L) PENICILLIUM ROQUEFORTI 0.0167 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0363-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0363-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0363-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0363-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0363-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 GRAIN SMUT MIXTURE
grain smut mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0213 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO NUDA HORDEI (UNII: 9Y53ZS6I82) (USTILAGO NUDA HORDEI - UNII:9Y53ZS6I82) USTILAGO NUDA HORDEI 0.005 g in 1 mL USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.005 g in 1 mL USTILAGO AVENAE (UNII: YIH315U1TU) (USTILAGO AVENAE - UNII:YIH315U1TU) USTILAGO AVENAE 0.005 g in 1 mL USTILAGO TRITICI (UNII: BV82OL2IZ8) (USTILAGO TRITICI - UNII:BV82OL2IZ8) USTILAGO TRITICI 0.005 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0213-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0213-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0213-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0213-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0213-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 09/09/1997 GRAIN SMUT MIXTURE
grain smut mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0212 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO NUDA HORDEI (UNII: 9Y53ZS6I82) (USTILAGO NUDA HORDEI - UNII:9Y53ZS6I82) USTILAGO NUDA HORDEI 0.0125 g in 1 mL USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.0125 g in 1 mL USTILAGO AVENAE (UNII: YIH315U1TU) (USTILAGO AVENAE - UNII:YIH315U1TU) USTILAGO AVENAE 0.0125 g in 1 mL USTILAGO TRITICI (UNII: BV82OL2IZ8) (USTILAGO TRITICI - UNII:BV82OL2IZ8) USTILAGO TRITICI 0.0125 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0212-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0212-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0212-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0212-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0212-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 09/09/1997 GRASS SMUT MIXTURE
grass smut mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0216 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO CYNODONTIS (UNII: 0V3J4YEX2W) (USTILAGO CYNODONTIS - UNII:0V3J4YEX2W) USTILAGO CYNODONTIS 0.01 g in 1 mL SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 0.01 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0216-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0216-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0216-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0216-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0216-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 GRASS SMUT MIXTURE
grass smut mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0215 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO CYNODONTIS (UNII: 0V3J4YEX2W) (USTILAGO CYNODONTIS - UNII:0V3J4YEX2W) USTILAGO CYNODONTIS 0.025 g in 1 mL SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0215-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0215-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0215-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0215-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0215-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 B MOLD MIXTURE
b mold mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0037 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOTHECIUM ROSEUM (UNII: TGO054E31O) (TRICHOTHECIUM ROSEUM - UNII:TGO054E31O) TRICHOTHECIUM ROSEUM 0.0018 g in 1 mL PASSALORA FULVA (UNII: HR6H5057CO) (PASSALORA FULVA - UNII:HR6H5057CO) PASSALORA FULVA 0.0018 g in 1 mL COCHLIOBOLUS SPICIFER (UNII: 91M9RWP3TD) (COCHLIOBOLUS SPICIFER - UNII:91M9RWP3TD) COCHLIOBOLUS SPICIFER 0.0018 g in 1 mL MYROTHECIUM VERRUCARIA (UNII: W5U19AK212) (MYROTHECIUM VERRUCARIA - UNII:W5U19AK212) MYROTHECIUM VERRUCARIA 0.0018 g in 1 mL HYPOMYCES PERNICIOSUS (UNII: 6K41G30A6U) (HYPOMYCES PERNICIOSUS - UNII:6K41G30A6U) HYPOMYCES PERNICIOSUS 0.0018 g in 1 mL NEUROSPORA CRASSA (UNII: 1X92VM01YP) (NEUROSPORA CRASSA - UNII:1X92VM01YP) NEUROSPORA CRASSA 0.0018 g in 1 mL KHUSKIA ORYZAE (UNII: VK8C112WTS) (KHUSKIA ORYZAE - UNII:VK8C112WTS) KHUSKIA ORYZAE 0.0018 g in 1 mL PAECILOMYCES VARIOTII (UNII: KO7V58BY40) (PAECILOMYCES VARIOTII - UNII:KO7V58BY40) PAECILOMYCES VARIOTII 0.0036 g in 1 mL MICROASCUS BREVICAULIS (UNII: DHI513VXU7) (MICROASCUS BREVICAULIS - UNII:DHI513VXU7) MICROASCUS BREVICAULIS 0.0018 g in 1 mL COLLETOTRICHUM COCCODES (UNII: Y0M7LGE3Z8) (COLLETOTRICHUM COCCODES - UNII:Y0M7LGE3Z8) COLLETOTRICHUM COCCODES 0.0018 g in 1 mL PLEOSPORA HERBARUM (UNII: 0N3Z1P4B2W) (PLEOSPORA HERBARUM - UNII:0N3Z1P4B2W) PLEOSPORA HERBARUM 0.0018 g in 1 mL STREPTOMYCES GRISEUS (UNII: G0O5980Z7W) (STREPTOMYCES GRISEUS - UNII:G0O5980Z7W) STREPTOMYCES GRISEUS 0.0018 g in 1 mL TRICHODERMA VIRIDE (UNII: T8678F0P0Q) (TRICHODERMA VIRIDE - UNII:T8678F0P0Q) TRICHODERMA VIRIDE 0.0018 g in 1 mL TRICHOPHYTON SCHOENLEINII (UNII: Z4MD1809H1) (TRICHOPHYTON SCHOENLEINII - UNII:Z4MD1809H1) TRICHOPHYTON SCHOENLEINII 0.0018 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 g in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0037-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0037-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0037-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0037-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0037-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 B MOLD MIXTURE
b mold mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0036 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOTHECIUM ROSEUM (UNII: TGO054E31O) (TRICHOTHECIUM ROSEUM - UNII:TGO054E31O) TRICHOTHECIUM ROSEUM 0.0036 g in 1 mL PASSALORA FULVA (UNII: HR6H5057CO) (PASSALORA FULVA - UNII:HR6H5057CO) PASSALORA FULVA 0.0036 g in 1 mL COCHLIOBOLUS SPICIFER (UNII: 91M9RWP3TD) (COCHLIOBOLUS SPICIFER - UNII:91M9RWP3TD) COCHLIOBOLUS SPICIFER 0.0036 g in 1 mL MYROTHECIUM VERRUCARIA (UNII: W5U19AK212) (MYROTHECIUM VERRUCARIA - UNII:W5U19AK212) MYROTHECIUM VERRUCARIA 0.0036 g in 1 mL HYPOMYCES PERNICIOSUS (UNII: 6K41G30A6U) (HYPOMYCES PERNICIOSUS - UNII:6K41G30A6U) HYPOMYCES PERNICIOSUS 0.0036 g in 1 mL NEUROSPORA CRASSA (UNII: 1X92VM01YP) (NEUROSPORA CRASSA - UNII:1X92VM01YP) NEUROSPORA CRASSA 0.0036 g in 1 mL KHUSKIA ORYZAE (UNII: VK8C112WTS) (KHUSKIA ORYZAE - UNII:VK8C112WTS) KHUSKIA ORYZAE 0.0036 g in 1 mL PAECILOMYCES VARIOTII (UNII: KO7V58BY40) (PAECILOMYCES VARIOTII - UNII:KO7V58BY40) PAECILOMYCES VARIOTII 0.0036 g in 1 mL MICROASCUS BREVICAULIS (UNII: DHI513VXU7) (MICROASCUS BREVICAULIS - UNII:DHI513VXU7) MICROASCUS BREVICAULIS 0.0036 g in 1 mL COLLETOTRICHUM COCCODES (UNII: Y0M7LGE3Z8) (COLLETOTRICHUM COCCODES - UNII:Y0M7LGE3Z8) COLLETOTRICHUM COCCODES 0.0036 g in 1 mL PLEOSPORA HERBARUM (UNII: 0N3Z1P4B2W) (PLEOSPORA HERBARUM - UNII:0N3Z1P4B2W) PLEOSPORA HERBARUM 0.0036 g in 1 mL STREPTOMYCES GRISEUS (UNII: G0O5980Z7W) (STREPTOMYCES GRISEUS - UNII:G0O5980Z7W) STREPTOMYCES GRISEUS 0.0036 g in 1 mL TRICHODERMA VIRIDE (UNII: T8678F0P0Q) (TRICHODERMA VIRIDE - UNII:T8678F0P0Q) TRICHODERMA VIRIDE 0.0036 g in 1 mL TRICHOPHYTON SCHOENLEINII (UNII: Z4MD1809H1) (TRICHOPHYTON SCHOENLEINII - UNII:Z4MD1809H1) TRICHOPHYTON SCHOENLEINII 0.0036 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 g in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0036-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0036-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0036-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0036-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0036-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 A MOLD MIXTURE
a mold mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0005 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FLAVUS (UNII: 3J888Y9L13) (ASPERGILLUS FLAVUS - UNII:3J888Y9L13) ASPERGILLUS FLAVUS 0.0008 g in 1 mL ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.0008 g in 1 mL ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.0008 g in 1 mL ASPERGILLUS REPENS (UNII: SQ89E6LOME) (ASPERGILLUS REPENS - UNII:SQ89E6LOME) ASPERGILLUS REPENS 0.0008 g in 1 mL BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 0.0033 g in 1 mL CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 0.0033 g in 1 mL EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.0033 g in 1 mL FUSARIUM OXYSPORUM (UNII: 5398RXP8KU) (FUSARIUM OXYSPORUM - UNII:5398RXP8KU) FUSARIUM OXYSPORUM 0.0033 g in 1 mL GEOTRICHUM CANDIDUM (UNII: 5964J742O8) (GEOTRICHUM CANDIDUM - UNII:5964J742O8) GEOTRICHUM CANDIDUM 0.0033 g in 1 mL COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.0033 g in 1 mL CANDIDA TROPICALIS (UNII: Q222J2186W) (CANDIDA TROPICALIS - UNII:Q222J2186W) CANDIDA TROPICALIS 0.0017 g in 1 mL NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 0.0017 g in 1 mL MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 0.0011 g in 1 mL MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.0011 g in 1 mL PENICILLIUM CAMEMBERTI (UNII: T069R9OPVG) (PENICILLIUM CAMEMBERTI - UNII:T069R9OPVG) PENICILLIUM CAMEMBERTI 0.0006 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0006 g in 1 mL PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z) PENICILLIUM EXPANSUM 0.0006 g in 1 mL PENICILLIUM ITALICUM (UNII: AZJ5XKM7W3) (PENICILLIUM ITALICUM - UNII:AZJ5XKM7W3) PENICILLIUM ITALICUM 0.0006 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0006 g in 1 mL PENICILLIUM ROQUEFORTI (UNII: 7ORP6R724L) (PENICILLIUM ROQUEFORTI - UNII:7ORP6R724L) PENICILLIUM ROQUEFORTI 0.0006 g in 1 mL PHOMA DESTRUCTIVA (UNII: A17SE577FM) (PHOMA DESTRUCTIVA - UNII:A17SE577FM) PHOMA DESTRUCTIVA 0.0033 g in 1 mL AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.0033 g in 1 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.0033 g in 1 mL RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 0.0033 g in 1 mL SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE 0.0033 g in 1 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.0011 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0005-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0005-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0005-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0005-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0005-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 PENICILLIUM NOTATUM
penicillium notatum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0417 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0417-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0417-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0417-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0417-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0417-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 MUCOR MIXTURE
mucor mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0295 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 0.0167 g in 1 mL MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.0167 g in 1 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.0167 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0295-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0295-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0295-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0295-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0295-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 A MOLD MIXTURE
a mold mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0006 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FLAVUS (UNII: 3J888Y9L13) (ASPERGILLUS FLAVUS - UNII:3J888Y9L13) ASPERGILLUS FLAVUS 0.0004 g in 1 mL ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.0004 g in 1 mL ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.0004 g in 1 mL ASPERGILLUS REPENS (UNII: SQ89E6LOME) (ASPERGILLUS REPENS - UNII:SQ89E6LOME) ASPERGILLUS REPENS 0.0004 g in 1 mL BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 0.0017 g in 1 mL CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 0.0017 g in 1 mL EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.0017 g in 1 mL FUSARIUM OXYSPORUM (UNII: 5398RXP8KU) (FUSARIUM OXYSPORUM - UNII:5398RXP8KU) FUSARIUM OXYSPORUM 0.0017 g in 1 mL GEOTRICHUM CANDIDUM (UNII: 5964J742O8) (GEOTRICHUM CANDIDUM - UNII:5964J742O8) GEOTRICHUM CANDIDUM 0.0017 g in 1 mL COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.0017 g in 1 mL CANDIDA TROPICALIS (UNII: Q222J2186W) (CANDIDA TROPICALIS - UNII:Q222J2186W) CANDIDA TROPICALIS 0.0008 g in 1 mL NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 0.0008 g in 1 mL MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 0.0006 g in 1 mL MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.0006 g in 1 mL PENICILLIUM CAMEMBERTI (UNII: T069R9OPVG) (PENICILLIUM CAMEMBERTI - UNII:T069R9OPVG) PENICILLIUM CAMEMBERTI 0.0003 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0003 g in 1 mL PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z) PENICILLIUM EXPANSUM 0.0003 g in 1 mL PENICILLIUM ITALICUM (UNII: AZJ5XKM7W3) (PENICILLIUM ITALICUM - UNII:AZJ5XKM7W3) PENICILLIUM ITALICUM 0.0003 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0003 g in 1 mL PENICILLIUM ROQUEFORTI (UNII: 7ORP6R724L) (PENICILLIUM ROQUEFORTI - UNII:7ORP6R724L) PENICILLIUM ROQUEFORTI 0.0003 g in 1 mL PHOMA DESTRUCTIVA (UNII: A17SE577FM) (PHOMA DESTRUCTIVA - UNII:A17SE577FM) PHOMA DESTRUCTIVA 0.0017 g in 1 mL AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.0017 g in 1 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.0017 g in 1 mL RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 0.0017 g in 1 mL SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE 0.0017 g in 1 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.0006 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0006-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0006-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0006-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0006-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0006-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 TRICHOPHYTON MIXTURE
trichophyton mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0577 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 0.025 g in 1 mL TRICHOPHYTON RUBRUM (UNII: 2ZAU32517N) (TRICHOPHYTON RUBRUM - UNII:2ZAU32517N) TRICHOPHYTON RUBRUM 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0577-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0577-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0577-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0577-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0577-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 PENICILLIUM MIXTURE
penicillium mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0364 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CAMEMBERTI (UNII: T069R9OPVG) (PENICILLIUM CAMEMBERTI - UNII:T069R9OPVG) PENICILLIUM CAMEMBERTI 0.0083 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0083 g in 1 mL PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z) PENICILLIUM EXPANSUM 0.0083 g in 1 mL PENICILLIUM ITALICUM (UNII: AZJ5XKM7W3) (PENICILLIUM ITALICUM - UNII:AZJ5XKM7W3) PENICILLIUM ITALICUM 0.0083 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0083 g in 1 mL PENICILLIUM ROQUEFORTI (UNII: 7ORP6R724L) (PENICILLIUM ROQUEFORTI - UNII:7ORP6R724L) PENICILLIUM ROQUEFORTI 0.0083 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0364-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0364-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0364-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0364-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0364-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 NUMBER TEN MOLD MIXTURE
number ten mold mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0587 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.005 g in 1 mL ASPERGILLUS FLAVUS (UNII: 3J888Y9L13) (ASPERGILLUS FLAVUS - UNII:3J888Y9L13) ASPERGILLUS FLAVUS 0.0013 g in 1 mL ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.0013 g in 1 mL ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.0013 g in 1 mL ASPERGILLUS REPENS (UNII: SQ89E6LOME) (ASPERGILLUS REPENS - UNII:SQ89E6LOME) ASPERGILLUS REPENS 0.0013 g in 1 mL FUSARIUM OXYSPORUM (UNII: 5398RXP8KU) (FUSARIUM OXYSPORUM - UNII:5398RXP8KU) FUSARIUM OXYSPORUM 0.005 g in 1 mL COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.005 g in 1 mL CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.005 g in 1 mL MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.005 g in 1 mL PENICILLIUM CAMEMBERTI (UNII: T069R9OPVG) (PENICILLIUM CAMEMBERTI - UNII:T069R9OPVG) PENICILLIUM CAMEMBERTI 0.0008 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0008 g in 1 mL PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z) PENICILLIUM EXPANSUM 0.0008 g in 1 mL PENICILLIUM ITALICUM (UNII: AZJ5XKM7W3) (PENICILLIUM ITALICUM - UNII:AZJ5XKM7W3) PENICILLIUM ITALICUM 0.0008 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0008 g in 1 mL PENICILLIUM ROQUEFORTI (UNII: 7ORP6R724L) (PENICILLIUM ROQUEFORTI - UNII:7ORP6R724L) PENICILLIUM ROQUEFORTI 0.0008 g in 1 mL PHOMA DESTRUCTIVA (UNII: A17SE577FM) (PHOMA DESTRUCTIVA - UNII:A17SE577FM) PHOMA DESTRUCTIVA 0.005 g in 1 mL AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.005 g in 1 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.005 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0587-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0587-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0587-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0587-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0587-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 TRICHOPHYTON MIXTURE
trichophyton mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0578 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 0.01 g in 1 mL TRICHOPHYTON RUBRUM (UNII: 2ZAU32517N) (TRICHOPHYTON RUBRUM - UNII:2ZAU32517N) TRICHOPHYTON RUBRUM 0.01 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0578-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0578-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0578-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0578-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0578-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 PHOMA
phoma injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0366 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOMA DESTRUCTIVA (UNII: A17SE577FM) (PHOMA DESTRUCTIVA - UNII:A17SE577FM) PHOMA DESTRUCTIVA 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0366-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0366-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0366-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0366-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0366-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 NIGROSPORA
nigrospora injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0328 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KHUSKIA ORYZAE (UNII: VK8C112WTS) (KHUSKIA ORYZAE - UNII:VK8C112WTS) KHUSKIA ORYZAE 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0328-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0328-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0328-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0328-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0328-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 PULLULARIA
pullularia injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0369 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0369-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0369-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0369-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0369-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0369-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 PULLULARIA
pullularia injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0368 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0368-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0368-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0368-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0368-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0368-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 CANDIDA ALBICANS
candida albicans injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0313 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0313-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0313-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0313-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0313-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0313-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 MYCOGONE PERNICIOSA
mycogone perniciosa injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0297 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPOMYCES PERNICIOSUS (UNII: 6K41G30A6U) (HYPOMYCES PERNICIOSUS - UNII:6K41G30A6U) HYPOMYCES PERNICIOSUS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0297-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0297-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0297-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0297-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0297-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 MUCOR RACEMOSUS
mucor racemosus injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0319 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0319-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0319-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0319-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0319-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0319-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 CANDIDA ALBICANS
candida albicans injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0314 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.02 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0314-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0314-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0314-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0314-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0314-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 TRICHODERMA
trichoderma injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0563 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHODERMA VIRIDE (UNII: T8678F0P0Q) (TRICHODERMA VIRIDE - UNII:T8678F0P0Q) TRICHODERMA VIRIDE 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0563-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0563-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0563-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0563-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0563-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 STACHYBOTRYS
stachybotrys injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0471 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STACHYBOTRYS CHARTARUM (UNII: HJ4L70T1ZP) (STACHYBOTRYS CHARTARUM - UNII:HJ4L70T1ZP) STACHYBOTRYS CHARTARUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0471-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0471-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0471-3 5 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0471-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0471-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 ASPERGILLUS MIXTURE
aspergillus mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0008 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FLAVUS (UNII: 3J888Y9L13) (ASPERGILLUS FLAVUS - UNII:3J888Y9L13) ASPERGILLUS FLAVUS 0.0125 g in 1 mL ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.0125 g in 1 mL ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.0125 g in 1 mL ASPERGILLUS REPENS (UNII: SQ89E6LOME) (ASPERGILLUS REPENS - UNII:SQ89E6LOME) ASPERGILLUS REPENS 0.0125 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0008-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0008-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0008-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0008-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0008-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 TRICHOPHYTON RUBRUM
trichophyton rubrum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0580 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON RUBRUM (UNII: 2ZAU32517N) (TRICHOPHYTON RUBRUM - UNII:2ZAU32517N) TRICHOPHYTON RUBRUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0580-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0580-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0580-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0580-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0580-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 RHIZOPUS
rhizopus injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0435 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0435-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0435-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0435-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0435-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0435-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 PAECILOMYCES
paecilomyces injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0371 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAECILOMYCES VARIOTII (UNII: KO7V58BY40) (PAECILOMYCES VARIOTII - UNII:KO7V58BY40) PAECILOMYCES VARIOTII 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0025 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0371-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0371-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0371-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0371-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0371-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 STEMPHYLIUM
stemphylium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0467 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLEOSPORA HERBARUM (UNII: 0N3Z1P4B2W) (PLEOSPORA HERBARUM - UNII:0N3Z1P4B2W) PLEOSPORA HERBARUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0467-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0467-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0467-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0467-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0467-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 SPONDYLOCLADIUM
spondylocladium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0465 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COLLETOTRICHUM COCCODES (UNII: Y0M7LGE3Z8) (COLLETOTRICHUM COCCODES - UNII:Y0M7LGE3Z8) COLLETOTRICHUM COCCODES 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0465-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0465-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0465-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0465-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0465-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 WHEAT SMUT
wheat smut injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0607 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO TRITICI (UNII: BV82OL2IZ8) (USTILAGO TRITICI - UNII:BV82OL2IZ8) USTILAGO TRITICI 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0607-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0607-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0607-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0607-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0607-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 09/09/1997 GLIOCLADIUM
gliocladium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0217 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MYROTHECIUM VERRUCARIA (UNII: W5U19AK212) (MYROTHECIUM VERRUCARIA - UNII:W5U19AK212) MYROTHECIUM VERRUCARIA 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0217-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0217-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0217-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0217-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0217-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 FUSARIUM OXYSPORUM
fusarium oxysporum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0197 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM (UNII: 5398RXP8KU) (FUSARIUM OXYSPORUM - UNII:5398RXP8KU) FUSARIUM OXYSPORUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0197-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0197-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0197-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0197-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0197-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 HORMODENDRUM
hormodendrum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0244 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0244-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0244-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0244-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0244-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0244-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 GEOTRICHUM CANDIDUM
geotrichum candidum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0228 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GEOTRICHUM CANDIDUM (UNII: 5964J742O8) (GEOTRICHUM CANDIDUM - UNII:5964J742O8) GEOTRICHUM CANDIDUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0228-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0228-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0228-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0228-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0228-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 CLADOSPORIUM HERBARUM
cladosporium herbarum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0158 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM HERBARUM (UNII: O64JF11198) (CLADOSPORIUM HERBARUM - UNII:O64JF11198) CLADOSPORIUM HERBARUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0158-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0158-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0158-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0158-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0158-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 CORN SMUT
corn smut injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0143 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0143-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0143-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0143-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0143-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0143-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 09/09/1977 EPIDERMOPHYTON
epidermophyton injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0194 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPIDERMOPHYTON FLOCCOSUM (UNII: 6JR6JTN25S) (EPIDERMOPHYTON FLOCCOSUM - UNII:6JR6JTN25S) EPIDERMOPHYTON FLOCCOSUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0194-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0194-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0194-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0194-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0194-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 EPICOCCUM
epicoccum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0186 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0186-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0186-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0186-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0186-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0186-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 CANDIDA ALBICANS
candida albicans injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0312 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0312-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0312-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0312-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0312-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0312-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 CANDIDA TROPICALIS
candida tropicalis injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0320 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA TROPICALIS (UNII: Q222J2186W) (CANDIDA TROPICALIS - UNII:Q222J2186W) CANDIDA TROPICALIS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0320-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0320-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0320-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0320-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0320-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 MUCOR RACEMOSUS
mucor racemosus injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0318 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0318-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0318-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0318-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0318-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0318-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 JOHNSON GRASS SMUT
johnson grass smut injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0278 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0278-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0278-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0278-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0278-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0278-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 HELMINTHOSPORIUM
helminthosporium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0247 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0247-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0247-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0247-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0247-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0247-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 MICROSPORUM AUDOUINII
microsporum audouinii injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0298 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICROSPORUM AUDOUINII (UNII: B7B86Y84R8) (MICROSPORUM AUDOUINII - UNII:B7B86Y84R8) MICROSPORUM AUDOUINII 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0298-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0298-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0298-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0298-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0298-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 MYCOGONE PERNICIOSA
mycogone perniciosa injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0296 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPOMYCES PERNICIOSUS (UNII: 6K41G30A6U) (HYPOMYCES PERNICIOSUS - UNII:6K41G30A6U) HYPOMYCES PERNICIOSUS 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0296-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0296-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0296-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0296-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0296-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0030 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0030-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0030-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0030-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0030-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0030-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 ASPERGILLUS REPENS
aspergillus repens injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0621 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS REPENS (UNII: SQ89E6LOME) (ASPERGILLUS REPENS - UNII:SQ89E6LOME) ASPERGILLUS REPENS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0621-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0621-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0621-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0621-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0621-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 ASPERGILLUS NIGER
aspergillus niger injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0032 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0032-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0032-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0032-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0032-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0032-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 ASPERGILLUS FLAVUS
aspergillus flavus injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0624 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FLAVUS (UNII: 3J888Y9L13) (ASPERGILLUS FLAVUS - UNII:3J888Y9L13) ASPERGILLUS FLAVUS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0624-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0624-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0624-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0624-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0624-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 TRICHOPHYTON SCHOENLEINII
trichophyton schoenleinii injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0618 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON SCHOENLEINII (UNII: Z4MD1809H1) (TRICHOPHYTON SCHOENLEINII - UNII:Z4MD1809H1) TRICHOPHYTON SCHOENLEINII 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0618-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0618-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0618-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0618-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0618-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 ALTERNARIA ALTERNATA
alternaria alternata injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0001 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0001-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0001-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0001-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0001-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0001-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 ACROTHECIUM ROBUSTUM
acrothecium robustum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0620 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACROTHECIUM ROBUSTUM (UNII: C91ZMT66YA) (ACROTHECIUM ROBUSTUM - UNII:C91ZMT66YA) ACROTHECIUM ROBUSTUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0620-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0620-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0620-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0620-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0620-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 ABSIDIA RAMOSA
absidia ramosa injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0619 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MYCOCLADUS CORYMBIFERUS (UNII: 1M4E76V32I) (MYCOCLADUS CORYMBIFERUS - UNII:1M4E76V32I) MYCOCLADUS CORYMBIFERUS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0619-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0619-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0619-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0619-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0619-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 CEPHALOTHECIUM
cephalothecium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0095 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOTHECIUM ROSEUM (UNII: TGO054E31O) (TRICHOTHECIUM ROSEUM - UNII:TGO054E31O) TRICHOTHECIUM ROSEUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0095-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0095-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0095-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0095-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0095-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 CHAETOMIUM
chaetomium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0093 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0093-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0093-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0093-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0093-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0093-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 CURVULARIA
curvularia injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0097 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SPICIFER (UNII: 91M9RWP3TD) (COCHLIOBOLUS SPICIFER - UNII:91M9RWP3TD) COCHLIOBOLUS SPICIFER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0097-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0097-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0097-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0097-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0097-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 CLADOSPORIUM FULVUM
cladosporium fulvum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0096 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASSALORA FULVA (UNII: HR6H5057CO) (PASSALORA FULVA - UNII:HR6H5057CO) PASSALORA FULVA 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0096-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0096-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0096-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0096-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0096-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 BERMUDA GRASS SMUT
bermuda grass smut injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0064 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO CYNODONTIS (UNII: 0V3J4YEX2W) (USTILAGO CYNODONTIS - UNII:0V3J4YEX2W) USTILAGO CYNODONTIS 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0064-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0064-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0064-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0064-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0064-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 BOTRYTIS
botrytis injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0038 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0038-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0038-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0038-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0038-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0038-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 CEPHALOSPORIUM
cephalosporium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0087 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACREMONIUM STRICTUM (UNII: 3F36V0451W) (ACREMONIUM STRICTUM - UNII:3F36V0451W) ACREMONIUM STRICTUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0087-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0087-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0087-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0087-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0087-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 BARLEY SMUT
barley smut injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0066 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO NUDA HORDEI (UNII: 9Y53ZS6I82) (USTILAGO NUDA HORDEI - UNII:9Y53ZS6I82) USTILAGO NUDA HORDEI 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0066-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0066-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0066-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0066-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0066-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 SPONDYLOCLADIUM
spondylocladium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0464 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COLLETOTRICHUM COCCODES (UNII: Y0M7LGE3Z8) (COLLETOTRICHUM COCCODES - UNII:Y0M7LGE3Z8) COLLETOTRICHUM COCCODES 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0464-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0464-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0464-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0464-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0464-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 SCOPULARIOPSIS
scopulariopsis injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0463 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICROASCUS BREVICAULIS (UNII: DHI513VXU7) (MICROASCUS BREVICAULIS - UNII:DHI513VXU7) MICROASCUS BREVICAULIS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0463-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0463-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0463-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0463-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0463-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 STREPTOMYCES
streptomyces injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0468 Route of Administration SUBCONJUNCTIVAL, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STREPTOMYCES GRISEUS (UNII: G0O5980Z7W) (STREPTOMYCES GRISEUS - UNII:G0O5980Z7W) STREPTOMYCES GRISEUS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0468-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0468-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0468-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0468-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0468-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 STEMPHYLIUM
stemphylium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0466 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLEOSPORA HERBARUM (UNII: 0N3Z1P4B2W) (PLEOSPORA HERBARUM - UNII:0N3Z1P4B2W) PLEOSPORA HERBARUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0466-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0466-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0466-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0466-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0466-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 RHIZOPUS
rhizopus injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0434 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0434-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0434-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0434-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0434-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0434-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 PENICILLIUM ITALICUM
penicillium italicum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0651 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM ITALICUM (UNII: AZJ5XKM7W3) (PENICILLIUM ITALICUM - UNII:AZJ5XKM7W3) PENICILLIUM ITALICUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0651-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0651-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0651-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0651-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0651-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 SACCHAROMYCES
saccharomyces injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0462 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0462-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0462-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0462-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0462-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0462-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 RHODOTORULA
rhodotorula injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0436 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0436-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0436-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0436-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0436-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0436-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 TRICHOPHYTON RUBRUM
trichophyton rubrum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0579 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON RUBRUM (UNII: 2ZAU32517N) (TRICHOPHYTON RUBRUM - UNII:2ZAU32517N) TRICHOPHYTON RUBRUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0579-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0579-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0579-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0579-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0579-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 TETRACOCCOSPORIUM PAXIANUM
tetracoccosporium paxianum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0564 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRACOCCOSPORIUM PAXIANUM (UNII: KSY1AWN59I) (TETRACOCCOSPORIUM PAXIANUM - UNII:KSY1AWN59I) TETRACOCCOSPORIUM PAXIANUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0564-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0564-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0564-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0564-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0564-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 VERTICILLIUM
verticillium injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0594 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VERTICILLIUM ALBO-ATRUM (UNII: X92O101CS2) (VERTICILLIUM ALBO-ATRUM - UNII:X92O101CS2) VERTICILLIUM ALBO-ATRUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0594-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0594-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0594-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0594-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0594-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 TRICHOPHYTON MENTAGROPHYTES
trichophyton mentagrophytes injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0585 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0585-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0585-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0585-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0585-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0585-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 STACHYBOTRYS
stachybotrys injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0470 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STACHYBOTRYS CHARTARUM (UNII: HJ4L70T1ZP) (STACHYBOTRYS CHARTARUM - UNII:HJ4L70T1ZP) STACHYBOTRYS CHARTARUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0470-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0470-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0470-3 5 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0470-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0470-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 SPOROTRICHUM
sporotrichum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0469 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SPOROTRICHUM PRUINOSUM (UNII: H20KU95UBG) (SPOROTRICHUM PRUINOSUM - UNII:H20KU95UBG) SPOROTRICHUM PRUINOSUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0469-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0469-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0469-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0469-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0469-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 TRICHODERMA
trichoderma injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0562 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHODERMA VIRIDE (UNII: T8678F0P0Q) (TRICHODERMA VIRIDE - UNII:T8678F0P0Q) TRICHODERMA VIRIDE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0562-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0562-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0562-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0562-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0562-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 SYNCEPHALASTRUM
syncephalastrum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0472 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SYNCEPHALASTRUM RACEMOSUM (UNII: 2VWV12V9WR) (SYNCEPHALASTRUM RACEMOSUM - UNII:2VWV12V9WR) SYNCEPHALASTRUM RACEMOSUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0472-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0472-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0472-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0472-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0472-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 OAT SMUT
oat smut injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0342 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO AVENAE (UNII: YIH315U1TU) (USTILAGO AVENAE - UNII:YIH315U1TU) USTILAGO AVENAE 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0342-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0342-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0342-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0342-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0342-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 NIGROSPORA
nigrospora injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0327 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KHUSKIA ORYZAE (UNII: VK8C112WTS) (KHUSKIA ORYZAE - UNII:VK8C112WTS) KHUSKIA ORYZAE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0327-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0327-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0327-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0327-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0327-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 PULLULARIA
pullularia injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0367 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0367-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0367-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0367-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0367-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0367-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 PHOMA
phoma injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0365 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOMA DESTRUCTIVA (UNII: A17SE577FM) (PHOMA DESTRUCTIVA - UNII:A17SE577FM) PHOMA DESTRUCTIVA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0365-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0365-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0365-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0365-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0365-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 MUCOR MUCEDO
mucor mucedo injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0637 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0637-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0637-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0637-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0637-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0637-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 NEUROSPORA INTERMEDIA
neurospora intermedia injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0326 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0326-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0326-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0326-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0326-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0326-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 NEUROSPORA CRASSA
neurospora crassa injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0639 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEUROSPORA CRASSA (UNII: 1X92VM01YP) (NEUROSPORA CRASSA - UNII:1X92VM01YP) NEUROSPORA CRASSA 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0639-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0639-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0639-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0639-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0639-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 MUCOR PLUMBEUS
mucor plumbeus injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0638 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0638-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0638-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0638-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0638-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0638-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 PENICILLIUM CAMEMBERTII
penicillium camembertii injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0648 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CAMEMBERTI (UNII: T069R9OPVG) (PENICILLIUM CAMEMBERTI - UNII:T069R9OPVG) PENICILLIUM CAMEMBERTI 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0648-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0648-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0648-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0648-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0648-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 PENICILLIUM ROQUEFORTII
penicillium roquefortii injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0647 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM ROQUEFORTI (UNII: 7ORP6R724L) (PENICILLIUM ROQUEFORTI - UNII:7ORP6R724L) PENICILLIUM ROQUEFORTI 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0647-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0647-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0647-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0647-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0647-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 PENICILLIUM EXPANSUM
penicillium expansum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0650 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z) PENICILLIUM EXPANSUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0650-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0650-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0650-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0650-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0650-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 PENICILLIUM CHRYSOGENUM
penicillium chrysogenum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0649 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0649-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0649-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0649-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0649-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0649-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 PAPULARIA
papularia injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0372 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APIOSPORA MONTAGNEI (UNII: 49VI1ZSO06) (APIOSPORA MONTAGNEI - UNII:49VI1ZSO06) APIOSPORA MONTAGNEI 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0372-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0372-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0372-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0372-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0372-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 PAECILOMYCES
paecilomyces injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0370 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAECILOMYCES VARIOTII (UNII: KO7V58BY40) (PAECILOMYCES VARIOTII - UNII:KO7V58BY40) PAECILOMYCES VARIOTII 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL WATER (UNII: 059QF0KO0R) SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0370-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0370-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0370-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0370-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0370-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 PENICILLIUM NOTATUM
penicillium notatum injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0416 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0416-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0416-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0416-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0416-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0416-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 PHYCOMYCES
phycomyces injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0373 Route of Administration SUBCUTANEOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYCOMYCES BLAKESLEEANUS (UNII: 41Y752Y34M) (PHYCOMYCES BLAKESLEEANUS - UNII:41Y752Y34M) PHYCOMYCES BLAKESLEEANUS 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0373-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0373-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0373-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0373-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0373-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 HUMICOLA GRISEA
humicola grisea injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0635 Route of Administration INTRADERMAL, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HUMICOLA GRISEA (UNII: RZ55S3AQOJ) (HUMICOLA GRISEA - UNII:RZ55S3AQOJ) HUMICOLA GRISEA 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0635-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0635-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0635-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0635-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0635-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 C MOLD MIXTURE
c mold mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0090 Route of Administration INTRADERMAL, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MYCOCLADUS CORYMBIFERUS (UNII: 1M4E76V32I) (MYCOCLADUS CORYMBIFERUS - UNII:1M4E76V32I) MYCOCLADUS CORYMBIFERUS 0.0083 g in 1 mL ACROTHECIUM ROBUSTUM (UNII: C91ZMT66YA) (ACROTHECIUM ROBUSTUM - UNII:C91ZMT66YA) ACROTHECIUM ROBUSTUM 0.0083 g in 1 mL HUMICOLA GRISEA (UNII: RZ55S3AQOJ) (HUMICOLA GRISEA - UNII:RZ55S3AQOJ) HUMICOLA GRISEA 0.0083 g in 1 mL MICROSPORUM AUDOUINII (UNII: B7B86Y84R8) (MICROSPORUM AUDOUINII - UNII:B7B86Y84R8) MICROSPORUM AUDOUINII 0.0083 g in 1 mL MICROSPORUM CANIS (UNII: N4F4RQ7BY7) (MICROSPORUM CANIS - UNII:N4F4RQ7BY7) MICROSPORUM CANIS 0.0083 g in 1 mL APIOSPORA MONTAGNEI (UNII: 49VI1ZSO06) (APIOSPORA MONTAGNEI - UNII:49VI1ZSO06) APIOSPORA MONTAGNEI 0.0083 g in 1 mL PHYCOMYCES BLAKESLEEANUS (UNII: 41Y752Y34M) (PHYCOMYCES BLAKESLEEANUS - UNII:41Y752Y34M) PHYCOMYCES BLAKESLEEANUS 0.0083 g in 1 mL SPOROTRICHUM PRUINOSUM (UNII: H20KU95UBG) (SPOROTRICHUM PRUINOSUM - UNII:H20KU95UBG) SPOROTRICHUM PRUINOSUM 0.0083 g in 1 mL STACHYBOTRYS CHARTARUM (UNII: HJ4L70T1ZP) (STACHYBOTRYS CHARTARUM - UNII:HJ4L70T1ZP) STACHYBOTRYS CHARTARUM 0.0083 g in 1 mL SYNCEPHALASTRUM RACEMOSUM (UNII: 2VWV12V9WR) (SYNCEPHALASTRUM RACEMOSUM - UNII:2VWV12V9WR) SYNCEPHALASTRUM RACEMOSUM 0.0083 g in 1 mL TETRACOCCOSPORIUM PAXIANUM (UNII: KSY1AWN59I) (TETRACOCCOSPORIUM PAXIANUM - UNII:KSY1AWN59I) TETRACOCCOSPORIUM PAXIANUM 0.0083 g in 1 mL VERTICILLIUM ALBO-ATRUM (UNII: X92O101CS2) (VERTICILLIUM ALBO-ATRUM - UNII:X92O101CS2) VERTICILLIUM ALBO-ATRUM 0.0083 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0090-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0090-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0090-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0090-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0090-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 04/13/1992 C MOLD MIXTURE
c mold mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0091 Route of Administration INTRADERMAL, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MYCOCLADUS CORYMBIFERUS (UNII: 1M4E76V32I) (MYCOCLADUS CORYMBIFERUS - UNII:1M4E76V32I) MYCOCLADUS CORYMBIFERUS 0.0042 g in 1 mL ACROTHECIUM ROBUSTUM (UNII: C91ZMT66YA) (ACROTHECIUM ROBUSTUM - UNII:C91ZMT66YA) ACROTHECIUM ROBUSTUM 0.0042 g in 1 mL HUMICOLA GRISEA (UNII: RZ55S3AQOJ) (HUMICOLA GRISEA - UNII:RZ55S3AQOJ) HUMICOLA GRISEA 0.0042 g in 1 mL MICROSPORUM AUDOUINII (UNII: B7B86Y84R8) (MICROSPORUM AUDOUINII - UNII:B7B86Y84R8) MICROSPORUM AUDOUINII 0.0042 g in 1 mL MICROSPORUM CANIS (UNII: N4F4RQ7BY7) (MICROSPORUM CANIS - UNII:N4F4RQ7BY7) MICROSPORUM CANIS 0.0042 g in 1 mL APIOSPORA MONTAGNEI (UNII: 49VI1ZSO06) (APIOSPORA MONTAGNEI - UNII:49VI1ZSO06) APIOSPORA MONTAGNEI 0.0042 g in 1 mL PHYCOMYCES BLAKESLEEANUS (UNII: 41Y752Y34M) (PHYCOMYCES BLAKESLEEANUS - UNII:41Y752Y34M) PHYCOMYCES BLAKESLEEANUS 0.0042 g in 1 mL SPOROTRICHUM PRUINOSUM (UNII: H20KU95UBG) (SPOROTRICHUM PRUINOSUM - UNII:H20KU95UBG) SPOROTRICHUM PRUINOSUM 0.0042 g in 1 mL STACHYBOTRYS CHARTARUM (UNII: HJ4L70T1ZP) (STACHYBOTRYS CHARTARUM - UNII:HJ4L70T1ZP) STACHYBOTRYS CHARTARUM 0.0042 g in 1 mL SYNCEPHALASTRUM RACEMOSUM (UNII: 2VWV12V9WR) (SYNCEPHALASTRUM RACEMOSUM - UNII:2VWV12V9WR) SYNCEPHALASTRUM RACEMOSUM 0.0042 g in 1 mL TETRACOCCOSPORIUM PAXIANUM (UNII: KSY1AWN59I) (TETRACOCCOSPORIUM PAXIANUM - UNII:KSY1AWN59I) TETRACOCCOSPORIUM PAXIANUM 0.0042 g in 1 mL VERTICILLIUM ALBO-ATRUM (UNII: X92O101CS2) (VERTICILLIUM ALBO-ATRUM - UNII:X92O101CS2) VERTICILLIUM ALBO-ATRUM 0.0042 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0091-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0091-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0091-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0091-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0091-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 C MOLD MIXTURE
c mold mixture injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 49288-0092 Route of Administration INTRADERMAL, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MYCOCLADUS CORYMBIFERUS (UNII: 1M4E76V32I) (MYCOCLADUS CORYMBIFERUS - UNII:1M4E76V32I) MYCOCLADUS CORYMBIFERUS 0.0021 g in 1 mL ACROTHECIUM ROBUSTUM (UNII: C91ZMT66YA) (ACROTHECIUM ROBUSTUM - UNII:C91ZMT66YA) ACROTHECIUM ROBUSTUM 0.0021 g in 1 mL HUMICOLA GRISEA (UNII: RZ55S3AQOJ) (HUMICOLA GRISEA - UNII:RZ55S3AQOJ) HUMICOLA GRISEA 0.0021 g in 1 mL MICROSPORUM AUDOUINII (UNII: B7B86Y84R8) (MICROSPORUM AUDOUINII - UNII:B7B86Y84R8) MICROSPORUM AUDOUINII 0.0021 g in 1 mL MICROSPORUM CANIS (UNII: N4F4RQ7BY7) (MICROSPORUM CANIS - UNII:N4F4RQ7BY7) MICROSPORUM CANIS 0.0021 g in 1 mL APIOSPORA MONTAGNEI (UNII: 49VI1ZSO06) (APIOSPORA MONTAGNEI - UNII:49VI1ZSO06) APIOSPORA MONTAGNEI 0.0021 g in 1 mL PHYCOMYCES BLAKESLEEANUS (UNII: 41Y752Y34M) (PHYCOMYCES BLAKESLEEANUS - UNII:41Y752Y34M) PHYCOMYCES BLAKESLEEANUS 0.0021 g in 1 mL SPOROTRICHUM PRUINOSUM (UNII: H20KU95UBG) (SPOROTRICHUM PRUINOSUM - UNII:H20KU95UBG) SPOROTRICHUM PRUINOSUM 0.0021 g in 1 mL STACHYBOTRYS CHARTARUM (UNII: HJ4L70T1ZP) (STACHYBOTRYS CHARTARUM - UNII:HJ4L70T1ZP) STACHYBOTRYS CHARTARUM 0.0021 g in 1 mL SYNCEPHALASTRUM RACEMOSUM (UNII: 2VWV12V9WR) (SYNCEPHALASTRUM RACEMOSUM - UNII:2VWV12V9WR) SYNCEPHALASTRUM RACEMOSUM 0.0021 g in 1 mL TETRACOCCOSPORIUM PAXIANUM (UNII: KSY1AWN59I) (TETRACOCCOSPORIUM PAXIANUM - UNII:KSY1AWN59I) TETRACOCCOSPORIUM PAXIANUM 0.0021 g in 1 mL VERTICILLIUM ALBO-ATRUM (UNII: X92O101CS2) (VERTICILLIUM ALBO-ATRUM - UNII:X92O101CS2) VERTICILLIUM ALBO-ATRUM 0.0021 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.525 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.0095 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.0024 g in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 49288-0092-1 2 mL in 1 VIAL, MULTI-DOSE 2 NDC: 49288-0092-2 5 mL in 1 VIAL, MULTI-DOSE 3 NDC: 49288-0092-3 10 mL in 1 VIAL, MULTI-DOSE 4 NDC: 49288-0092-4 30 mL in 1 VIAL, MULTI-DOSE 5 NDC: 49288-0092-5 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102223 03/23/1974 Labeler - Antigen Laboratories, Inc. (030705628) Registrant - Antigen Laboratories, Inc. (030705628) Establishment Name Address ID/FEI Business Operations Antigen Laboratories, Inc. 030705628 manufacture
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