ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER- ap horse hair and dander injection, solution ANIMAL ALLERGENS, AP CATTLE HAIR AND DANDER- cattle hair and dander injection, solution ANIMAL ALLERGENS, AP DOG HAIR AND DANDER CANIS SPP- animal allergens, dog dander canis spp injection, solution ANIMAL ALLERGENS, DOG HAIR AND DANDER CANIS SPP. (dog hair ....... POLLENS - WEEDS AND GARDEN PLANTS, SCALE, WING SHAD ATRIPLEX CANESCENS (scale, wing shad atriplex canescens) injection, solution POLLENS - WEEDS AND GARDEN PLANTS, SCOTCH BROOM CYTISUS SCOPARIUS (scotch broom cytisus scoparius) injection, solution POLLENS - WEEDS AND GARDEN PLANTS, SORREL, SHEEP RUMEX ACETOSELLA- sorrel, sheep rumex acetosella injection, solution [Jubilant HollisterStier LLC] POLLENS - WEEDS AND GARDEN PLANTS, SCALE, WING SHAD ATRIPLEX CANESCENS- scale, wing shad atriplex canescens injection, solution POLLENS - WEEDS AND GARDEN PLANTS, SCOTCH BROOM CYTISUS SCOPARIUS- scotch broom cytisus scoparius injection, solution POLLENS - WEEDS AND GARDEN PLANTS, SORREL, SHEEP RUMEX ACETOSELLA- sorrel, sheep rumex acetosella injection, solution

Pollens - Weeds, Weed mix 2630 by

Drug Labeling and Warnings

Pollens - Weeds, Weed mix 2630 by is a Other medication manufactured, distributed, or labeled by Jubilant HollisterStier LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOXED WARNING

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WARNINGS

This product is intended for use only by licensed medical personnel experienced in administering allergenic extracts and trained to provide immediate emergency treatment in the event of a life-threatening reaction. Allergenic extracts may potentially elicit a severe life threatening systemic reaction, rarely resulting in death.7 Therefore, emergency measures and personnel trained in their use must be available immediately in the event of such a reaction. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if symptoms occur. Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions. This product should never be injected intravenously. Refer also to the WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS Sections for further discussion.

DESCRIPTION

Sterile extracts for scratch, prick or puncture testing are supplied in dropper vials containing, in addition to the extract allergens and antigens, 50% (v/v) glycerin as preservative, 0.5% sodium chloride and 0.275% sodium bicarbonate. The strength of these extracts may be expressed in terms of

• Weight to Volume (w/v)
• Protein Nitrogen Units/mL (PNU/mL)
• Amb a 1 Units/mL (Amb a 1/mL)
• Allergy Units/mL (AU/mL)
• Bioequivalent Allergy Units/mL (BAU/mL)
• Concentrate

1. Weight to volume (w/v).
For regular extracts this describes the extraction ratio, i.e., the amount of crude allergen added to the extracting fluid. A 1:10 extract, therefore, indicates that the solution contains the extracted material from one gram of raw material added to each 10 mL of extracting fluid. The amount and composition of extracted materials will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. AP™ (acetone precipitated) extracts, if present, are prepared by reconstituting dry, allergenically active concentrates produced by precipitation process from extracts of raw materials. For those AP™ extracts labeled on a weight per volume (w/v) basis, the strength designation indicates the dry weight of finished (acetone) precipitate per volume of reconstituting fluid. For example, 1:50 (w/v) means that each gram of dry precipitate obtained from the original extract is reconstituted in 50 mL of solution.

2. Protein Nitrogen Units per mL (PNU/mL).
One protein nitrogen unit represents 0.00001 mg phosphotungstic acid-precipitable protein nitrogen dissolved in one mL of antigen extract. The PNU content of extracts of the same antigen may vary according to the method of measuring the PNU. Thus, the PNU content of extracts from different manufacturers is not comparable unless the PNU method is known to be the same and reproducible from lot to lot. Also, the amount of protein nitrogen extracted from an antigen is influenced by the same variables as the weight to volume extract. Allergenic materials make up a variable proportion of the total protein of an extract.

3. Amb a 1.  Of the many allergens which have been purified and characterized from Short Ragweed (Amb a 112, Amb a 213, Ra314, Ra4(BPA-R)15, Ra516, Ra6, Ra7, and Ra817, and cytochrome C18), Amb a 1 (also known as Antigen E) is considered the most important and has been selected as the basis for standardization. Extracts of Short Ragweed containing Amb a 1 are diffused in agar against standard anti-serum to Amb a 1, and compared to the diffusion of standard Amb a 1 solutions. The amount of Amb a 1 is expressed as units of Amb a 1 per mL of extract.

If an extract is diluted with a diluent or other allergenic extracts, the Amb a 1 concentration must be determined by calculation.

4. Allergy Units per mL (AU/mL).
The potency of extracts labeled in Allergy Units per mL (AU/mL) is determined by in vitro comparison to a reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA).

5. Bioequivalent Allergy Units per mL (BAU/mL).
When originally licensed, the Reference Preparations for standardized extracts were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method 13 was used to determine that some Reference Preparations should be assigned 10,000 AU/mL, and others 100,000 AU/mL. To avoid possible confusion about this change in the method of allergy unit assignment, the nomenclature changed for standardized extracts whose allergy units are assigned based on quantitative skin testing, and such products are labeled in Bioequivalent Allergy Units (BAU)/mL. References labeled 10,000 BAU/mL can be diluted one to a half million fold, and references labeled 100,000 BAU/mL can be diluted one to 5 million fold and produce a sum of erythema diameter of 50 mm when Intradermal testing highly reactive subjects.

6. Concentrate.
Concentrate label terminology applies to allergenic extract mixtures, where the individual allergens being combined vary in strength or the designation of strength.

CLINICAL PHARMACOLOGY

Allergenic extracts for scratch, prick or puncture testing, used according to the DOSAGE AND ADMINISTRATION section, produce erythema or erythema and wheal reactions in patients with significant IgE-mediated sensitivity to the relevant allergen. This allergic inflammatory response, although not completely understood, is thought to begin with reaction of antigen with IgE on the surface of basophils or mast cells, which initiates a series of biochemical events resulting in the production of histamine and other mediators. These, in turn, produce the immediate-type "wheal and flare" skin reaction.

INDICATIONS & USAGE

Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established. 14
In addition to a carefully taken history, the use of glycerin-containing extracts in scratch, prick or puncture testing is an accepted method in the diagnosis of allergic conditions. 1, 2, 3 Extracts of all allergens do not produce equivalent results in scratch, prick or puncture tests. The intensity of the skin reactions produced will be determined by two factors: the degree of sensitivity of the patient, and the nature of the allergenic extract applied.
Scratch, prick or puncture tests are not as sensitive as the intradermal test, but are safer and cause less discomfort. They may, therefore, be the method of choice when a large number of tests are needed, or when testing the pediatric patient. In some cases, where the relatively insensitive scratch, prick or puncture tests are negative or do not confirm the allergic history, follow-up intradermal tests may be positive. However, ANTIGENS PRODUCING LARGE 3 to 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY.

CONTRAINDICATIONS

There are no known absolute contraindications to allergy skin testing. Patients with cardiovascular diseases or pulmonary diseases such as symptomatic asthma, and/or who are receiving cardiovascular drugs such as beta blockers, may be at higher risk for severe adverse reactions. These patients may also be more refractory to the normal anaphylaxis treatment regimen.

WARNINGS

Excessively large local reactions or systemic reactions are more likely to occur if the patient is skin tested shortly after exposure to large amounts of antigen to which s/he is sensitive. Use caution when skin testing patients during a season when pollen is present. Refer to boxed WARNINGS Section.

PRECAUTIONS

1. General

Always have injectable epinephrine and a tourniquet available when tests are being made. (See ADVERSE REACTIONS section.) Generally 50 to 60 scratch, prick or puncture tests can be applied safely at one sitting. Patients whose history suggests severe sensitivity should have only 5 to 10 tests applied at a time and these tests applied to the volar surface of one arm. These tests should not all be of the same type of antigen; that is, all grass pollens, all weed pollens, all danders, etc. One or two tests from several classes of antigens should be applied at a time. As soon as a large wheal begins to develop, wipe the antigen from it with a damp cotton sponge. After 10 minutes wipe off all the antigens with a damp cotton sponge, followed by a dry cotton sponge. Be careful not to wipe antigen from a positive reaction onto an adjacent test site.

2 Information for Patients

Patients should be instructed in the recognition of adverse reactions to diagnostic testing. Patients should be made to understand the importance of a 30 minute observation period, and be warned to return to the office promptly if symptoms occur after leaving.

3. Drug Interactions

Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.6
Certain medications may lessen the skin test wheal and erythema responses elicited by allergens and histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing.9 Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing.9, 10 Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing.11 Topical local anesthetics may suppress the flare responses and should be
avoided in skin test sites.12

4. Carcinogenesis, mutagenesis, Impairment of Fertility

Long-term studies in animals have not been conducted with allergenic extracts to determine their potential for carcinogenicity, mutagenicity or impairment of fertility.

5. Pregnancy

4,5
Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extracts should be given to a pregnant woman only if clearly needed.

6. Nursing Mothers

There are no current studies on secretion of the allergenic extract components in human milk or effect on the nursing infant. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.

7. Pediatric Use

Wheal sizes in response to allergen skin testing can be smaller in infants than in adults. The skin response to histamine parallels that for allergens; therefore, appropriate positive control skin tests should always be performed.1

8. Geriatric Use

Skin test wheal size decreases with age. The decrease in allergen-induced skin test reaction parallels that to histamine; therefore, appropriate positive skin test controls should always be performed.1

ADVERSE REACTIONS

1. Local Reactions
If a severe local reaction occurs during scratch, prick or puncture testing, WIPE OFF test antigen. Large, persistent local reactions or minor exacerbations of the patient's allergic symptoms may be treated by local cold applications and/or the use of oral antihistamines, but they should be considered a warning of possible severe systemic reactions.

2. Systemic Reactions
With careful attention to dosage and administration, such reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent in sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions.
Adverse reaction frequency data for allergenic extract administration for testing and treatment show that risk is low.7, 8
It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is a possibility. Other possible systemic reaction symptoms include fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria. If a systemic or anaphylactic reaction does occur, WIPE OFF test antigen, apply a tourniquet above the site of injection, if tests are performed on the arms, and inject the 1:1,000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.

EPINEPHRINE:
ADULT DOSAGE: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary.
PEDIATRIC DOSAGE: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg (mL) per square meter of body surface area. Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient. After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and other appropriate drugs. Oxygen should be given by mask. Intravenous antihistamine, theophylline or corticosteroids may be used if necessary after adequate epinephrine and circulatory support have been given. Emergency resuscitation measures and personnel trained in their use should be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures (Ref. J. Allergy Clin. Immunol. 77 (2): 271-273, 1986). Rarely are all of the above measures necessary; the tourniquet and epinephrine usually produce prompt responses. However, the physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment measures is of utmost importance.

3. Adverse Event Reporting
Report all adverse events to Jubilant HollisterStier LLC Customer Technical Services Department at 1 (800) 992-1120. A voluntary adverse event reporting system for health professionals is available through the FDA MEDWATCH program. Preprinted forms (FDA Form 3500) are available from the FDA by calling 1 (800) FDA-1088. Completed forms should be mailed to MEDWATCH, 5600 Fisher Lane, Rockville, MD 20852-9787 or Fax to: 1 (800) FDA-0178.

OVERDOSAGE

See ADVERSE REACTIONS Section.

DOSAGE & ADMINISTRATION

1. General
Parenteral Drug Products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2. Scratch, Prick or Puncture Testing Methods
There are two general methods of skin testing. (1) The skin is scarified first, and the extract is then applied. (2) A drop of extract is put onto the skin, and a prick or puncture is made through the drop. Avoid touching tip of dropper to skin. Either method is satisfactory, but the second requires that the instrument be cleansed between tests or that separate needles be used.

The extracts for scratch, prick or puncture testing are supplied in dropper vials and should be kept in a rack or box in rows of 10 vials corresponding to the rows of tests to be applied to the skin.

All skin tests should be validated by appropriate positive control tests (e.g., histamine) and negative control tests (e.g., Glycerin, Albumin Saline with Phenol (0.4%), or Buffered Saline with Phenol). The negative control test should be the same material as is used as a diluting fluid in the tested extracts. Diluting fluid is used in the same way as an active test extract.

Test sites should be examined at 15 and 30 minutes. To prevent excessive absorption, wipe off antigens producing large reactions as soon as the wheal appears. Record the size of the reaction. Delayed reactions may rarely occur from tests, so it may be helpful to examine the test sites in 24 hours.

Use of Scarifiers and Spacing. Make scarifications at least 2.5 cm apart. Use more space between pollen tests to prevent smearing into adjacent sites. Hold the scarifier between the thumb and index finger, press the sharp edge of the instrument against the skin and twirl instrument rapidly. The scratch should disrupt only the outer layers of epidermis but should not produce immediate oozing of blood. The amount of pressure needed to produce a satisfactory scratch will vary between patients according to the thickness or fragility of their skin. Experience will indicate the proper amount of pressure to exert in making the scratch. If the scarifier is kept sharp and the scratch made quickly, discomfort to the patient is minimized.

Use of Prick Test Needles. The skin is cleaned and single drops of each extract applied to the properly identified test sites. A small, sterile disposable needle, such as a 1/2-inch 26 gauge needle (with the bevel up), a bifurcated vaccinating needle, or a Prick Lancetter™ is inserted through the drop superficially into the skin, the skin lifted slightly and the needle withdrawn. No bleeding should be produced. After about 1 minute the extract may be wiped away.

3. Most Satisfactory Sites for Testing
Prior to testing, clean the skin area to be tested with ether or alcohol and allow to dry. Use a sterile instrument for each patient. The back or the volar surface of the arms are the most satisfactory sites for testing. Skin of the posterior thighs or abdomen may be used if necessary. Avoid very hairy areas where possible, since the reactions will be smaller and more difficult to interpret. The most satisfactory areas of the back 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 of the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anti-cubital space.

4. Use of Antigen Mixes
The use of complicated mixes of unrelated pollens for testing is not recommended since in the case of a positive reaction, it does not indicate which pollen(s) are responsible, and, in the case of a negative reaction, it fails to indicate whether the individual pollens at full concentration would give a positive reaction.

5. Reading Skin Test Reactions
A positive reaction consists of an urticarial wheal with surrounding erythema (resembling somewhat a mosquito bite reaction) larger than the control site. The smallest reaction considered positive is erythema with a central papule at least 5 mm in diameter. In some instances with no reaction at the control site, erythema may be considered an indication of sensitivity. In general, the size of wheal and erythema response correlates directly with the patient’s sensitivity to that allergen.

Standardized Products
(a) Mites:
The skin test concentration of 30,000 AU/mL in dropper vials is used for scratch, prick or puncture testing. Puncture tests performed on 12 highly sensitive subjects showed the following:

Species	Mean Sum of Wheal ± Std. Dev. (mm)	Mean Sum of Erythema ± Std. Dev. (mm)
D. farinae	22.4 ± 10.7	82.2 ± 21.7
D. pteronyssinus	24.0 ± 9.9	89.3 ± 24.5

The sum of a skin response is the sum of the longest diameter and the mid-point orthogonal diameter.

(b) Cat Hair and Cat Pelt: The skin test concentration of 10,000 BAU/mL (10-19.9 Fel d 1 Units/mL) in dropper vials is used for prick or puncture testing. Puncture tests performed on 15 highly sensitive subjects showed the following:

Product	Mean Sum of Wheal ± Std. Dev (mm)	Mean Sum of Erythema ± Std. Dev (mm)
Standardized; Cat Hair	15.1 ± 3.8	73.3 ± 14.3
Standardized; Cat Pelt	13.9 ± 4.3	67.3 ± 13.3

The sum of a skin response is the sum of the longest diameter and the mid-point orthogonal diameter.

(c) Ragweed pollen (Short Ragweed or Giant and Short Ragweed Mixture) Antigen E Assayed: Short Ragweed extract at 1:20 w/v in 50% glycerin containing approximately 100 to 300 units of Amb a 1/mL or Giant and Short Ragweed Mix at 1:20 w/v in 50% glycerin containing approximately 50 to 150 units of Amb a 1/mL are usually used for scratch, prick or puncture testing.
Refer to the following table to determine the skin test sensitivity grade. The corresponding ∑E (sum of the longest diameter and the mid-point orthogonal diameters of erythema) is also presented.

Grade	Erythema; mm	Papule or Wheal; mm	Corresponding; mm ∑E
0	<5	<5	<10
±	5-10	5-10	10-20
1+	11-20	5-10	20-40
2+	21-30	5-10	40-60
3+	31-40	10-15 (a)	60-80
4+	>40	>15 (b)	>80

(a) or with pseudopods (b) or with many pseudopods

A positive skin reaction to any allergen must be interpreted in light of the patient’s history of symptoms, time of the year, and known exposures.

THE SKIN TESTS ARE IN NO WAY A SUBSTITUTE FOR A CAREFUL ALLERGIC HISTORY. THEY SERVE AS ADDITIONAL INFORMATION TO AID IN IDENTIFYING CAUSATIVE ALLERGENS IN PATIENTS WITH ALLERGIC DISORDERS.

6. Geriatric Use

The dose is the same in patients of all age groups. Because the wheal size in response to allergen skin testing decreases with age, appropriate histamine positive control skin tests must be performed.1

7. Pediatric Use

The dose is the same in patients of all age groups. Wheal size in response to allergen skin testing can be smaller in infants than in adults. Appropriate histamine positive control skin tests must be performed.1

HOW SUPPLIED

In 5 mL dropper bottles of extract at 1:10 w/v except pollen at 1:20, AP™ extracts at 1:50 w/v, except AP™ Dog Hair-Dander at 1:100 w/v, AP™ House Dust at 20,000 PNU/mL, some mixes as Concentrate, and Standardized products at AU/mL (Mite extracts at 30,000 AU/mL) or BAU/mL (Cat Hair and Pelt extracts at 10,000 BAU/mL) value. Strengths are listed on product labels. 

STORAGE

The expiration date of the diagnostic extracts is listed on the container label. The extract should be stored at 2° - 8°C and kept at this temperature range during office use.

LIMITED WARRANTY

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly, and that the directions be followed carefully during use. No warranty, express or implied, including any warranty of merchantability or fitness, is made. Representatives of the Company are not authorized to vary the terms or the contents of any printed labeling, including the package insert, for this product except by printed notice from the Company’s headquarters. The prescriber and user of this product must accept the terms hereof.

REFERENCES

1. Middleton, Elliott, Jr., C.E. Reed, E.F. Ellis (ed.) Allergy Principles and Practice. Fourth Edition, Vol. 1. C.V. Mosby. 1993.
2. Sheldon, J.M., R.G. Lovell, K.P. Mathews. A Manual of Clinical Allergy. W.B. Saunders. 1967.
3. Tuft, L., H.L. Mueller. Allergy in Children. W.B. Saunders. 1970.
4. DuBuske, L.M., C.J. Ling, A.L. Sheffer. Special problems regarding allergen immunotherapy. Immunol. Allergy Clin. North Am. (USA). 12(1): 145-175, 1992.
5. Weinstein, A.M., B.D. Dubin, W.K. Podleski, S.L. Spector, R.S. Farr. Asthma and pregnancy. JAMA. 124(11): 1161-1165, 1979.
6. Jacobs, Robert L., Geoffrey W. Rake, Jr., et.al. Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade. J. Allergy Clin. Immunol. 68(2): 125-127, August 1981.
7. Lockey, Richard F., Linda M. Benedict, Paul C. Turkeltaub, Samuel C. Bukantz. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 79(4): 660-677, 1987.
8. Turkeltaub, Paul C., Peter J. Gergen. The risk of adverse reactions from percutaneous prick-puncture allergen skin testing, venipuncture, and body measurements: Data from the second National Health and Nutrition Examination Survey 1976-80 (NHANES II). J. Allergy Clin. Immunol. 84(6): 886-890, Dec. 1989.
9. Pipkorn, Ulf. Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86, 1988.
10. Andersson, M., U. Pipkorn. Inhibition of the dermal immediate allergic reaction through prolonged treatment with topical glucocorticosteroids. J. Allergy Clin. Immunol. 79 (2): 345-349, February 1987.
11. Rao, Kamineni S., et al. Duration of suppressive effect of tricyclic anti-depressants on histamine induced wheal and flare reactions on human skin. J. Allergy Clin. Immunol. 82: 752-757, November 1988.
12. Pipkorn, Ulf, M. Andersson. Topical dermal anesthesia inhibits the flare but not the wheal response to allergen and histamine in the skin prick test. Clin. Allergy. 17: 307-311, 1987.
13. Turkeltaub, Paul C., Suresh, C. Rastogi, Harold Baer. Office of Biologics Research and Review skin test method for evaluation of subject sensitivity to standardized allergenic extracts and for assignment of allergy units to reference preparations using the ID50EAL method (Intradermal Dilution for 50 mm Sum of Erythema Determines the Allergy Unit). Methods of the Allergenic Products Branch Office of Biologics Research and Review, FDA, Bethesda, MD 20892. Revised May 9, 1986.
14. Food and Drug Administration. Biological products; Allergenic extracts classified in Category IIIB; Final order; Revocation of licenses. Federal Register. 59(220): 59228ff, November 16, 1994.

AP Cattle Hair-Dander, 5 mL 1:50 w/v Carton Label

AP Cattle Hair-Dander, 5 mL 1:50 w/v Vial Label

AP Dog Hair-Dander, 5 mL 1:100 w/v Carton Label

AP Dog Hair-Dander, 5 mL 1:100 w/v Vial Label

AP Horse Hair-Dander, 5 mL 1:50 w/v Carton Label

AP Horse Hair-Dander, 5 mL 1:50 w/v Vial Label

Dog Hair-Dander, 5 mL 1:10 w/v Carton Label

Dog Hair-Dander, 5 mL 1:10 w/v Vial Label

Feather Mix, 5 mL 1:10 w/v Carton Label

Feather Mix, 5 mL 1:10 w/v Vial Label

Guinea Pig Hair-Dander, 5 mL 1:10 w/v Carton Label

Guinea Pig Hair-Dander, 5 mL 1:10 w/v Vial Label

INGREDIENTS AND APPEARANCE

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER 
ap horse hair and dander injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-4856
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EQUUS CABALLUS HAIR (UNII: 4F35XG0149) (EQUUS CABALLUS HAIR - UNII:4F35XG0149)	EQUUS CABALLUS HAIR	0.01 g  in 1 mL
EQUUS CABALLUS DANDER (UNII: J81SZ18495) (EQUUS CABALLUS DANDER - UNII:J81SZ18495)	EQUUS CABALLUS DANDER	0.01 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-4856-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	01/30/1978

ANIMAL ALLERGENS, AP CATTLE HAIR AND DANDER 
cattle hair and dander injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-4812
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BOS TAURUS HAIR (UNII: TOQ97Z8644) (BOS TAURUS HAIR - UNII:TOQ97Z8644)	BOS TAURUS HAIR	0.01 g  in 1 mL
BOS TAURUS DANDER (UNII: C8VYS726O8) (BOS TAURUS DANDER - UNII:C8VYS726O8)	BOS TAURUS DANDER	0.01 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-4812-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	01/30/1978

ANIMAL ALLERGENS, AP DOG HAIR AND DANDER CANIS SPP 
animal allergens, dog dander canis spp injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-4825
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR)	CANIS LUPUS FAMILIARIS HAIR	0.005 g  in 1 mL
CANIS LUPUS FAMILIARIS DANDER (UNII: 11JCK302I4) (CANIS LUPUS FAMILIARIS DANDER - UNII:11JCK302I4)	CANIS LUPUS FAMILIARIS DANDER	0.005 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-4825-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	08/24/1976

ANIMAL ALLERGENS, DOG HAIR AND DANDER CANIS SPP. 
dog hair canis spp. injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-4084
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR)	CANIS LUPUS FAMILIARIS HAIR	0.05 g  in 1 mL
CANIS LUPUS FAMILIARIS DANDER (UNII: 11JCK302I4) (CANIS LUPUS FAMILIARIS DANDER - UNII:11JCK302I4)	CANIS LUPUS FAMILIARIS DANDER	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-4084-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

ANIMAL ALLERGENS, FEATHER MIX 
feather mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-4350
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GALLUS GALLUS FEATHER (UNII: 1FCM16V0FV) (GALLUS GALLUS FEATHER - UNII:1FCM16V0FV)	GALLUS GALLUS FEATHER	0.1 g  in 1 mL
ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796) (ANAS PLATYRHYNCHOS FEATHER - UNII:83B65P4796)	ANAS PLATYRHYNCHOS FEATHER	0.1 g  in 1 mL
ANSER ANSER FEATHER (UNII: 15XI414745) (ANSER ANSER FEATHER - UNII:15XI414745)	ANSER ANSER FEATHER	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-4350-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

ANIMAL ALLERGENS, GUINEA PIG HAIR AND DANDER 
guinea pig hair and dander injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-4402
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAVIA PORCELLUS HAIR (UNII: KBA5Y6X57N) (CAVIA PORCELLUS HAIR - UNII:KBA5Y6X57N)	CAVIA PORCELLUS HAIR	0.05 g  in 1 mL
CAVIA PORCELLUS DANDER (UNII: 84Q71TU5SU) (CAVIA PORCELLUS DANDER - UNII:84Q71TU5SU)	CAVIA PORCELLUS DANDER	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-4402-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, BEEF BOVINE SPP. 
beef bovine spp. injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-3078
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BEEF (UNII: 4PIB2155QP) (BEEF - UNII:4PIB2155QP)	BEEF	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-3078-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, CHICKEN MEAT GALLUS SP. 
chicken meat gallus sp. injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-3174
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POULTRY, UNSPECIFIED (UNII: L7WXO2P5HM) (POULTRY, UNSPECIFIED - UNII:L7WXO2P5HM)	POULTRY, UNSPECIFIED	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-3174-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, EGG, WHITE GALLUS SP. 
egg, white gallus sp. injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-3249
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EGG WHITE (UNII: 3E0I92Z2GR) (EGG WHITE - UNII:3E0I92Z2GR)	EGG WHITE	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-3249-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, EGG, YOLK GALLUS SP. 
egg, yolk gallus sp. injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-3255
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EGG YOLK (UNII: 4IPS17B70T) (EGG YOLK - UNII:4IPS17B70T)	EGG YOLK	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-3255-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, PORK SUS SP. 
pork sus sp. injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-3510
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PORK (UNII: O138UB266J) (PORK - UNII:O138UB266J)	PORK	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-3510-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - DAIRY PRODUCTS, CASEIN, COW MILK 
casein, cow milk injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-3381
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CASEIN (UNII: 48268V50D5) (CASEIN - UNII:48268V50D5)	CASEIN	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-3381-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - DAIRY PRODUCTS, MILK, WHOLE COW 
milk, whole cow injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-3390
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT)	COW MILK	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-3390-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, CARELESS WEED AMARANTHUS PALMERI 
careless weed amaranthus palmeri injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1298
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH)	AMARANTHUS PALMERI POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1298-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, CARELESS/PIGWEED MIX 
careless/pigweed mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1301
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH)	AMARANTHUS PALMERI POLLEN	0.05 g  in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW)	AMARANTHUS RETROFLEXUS POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1301-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, DOCK/SORREL MIX 
pollens - weeds, dock/sorrel mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1517
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G)	RUMEX CRISPUS POLLEN	0.05 g  in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW)	RUMEX ACETOSELLA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1517-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, GIANT, SHORT, WESTERN RAGWEED MIX 
giant, short, western ragweed mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2318
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX)	AMBROSIA TRIFIDA POLLEN	0.05 g  in 1 mL
AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3)	AMBROSIA ARTEMISIIFOLIA POLLEN	0.05 g  in 1 mL
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L)	AMBROSIA PSILOSTACHYA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2318-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, KOCHIA SCOPARIA 
kochia scoparia injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1781
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5)	BASSIA SCOPARIA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1781-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, MARSHELDER/POVERTY MIX 
pollens - weeds, marshelder/poverty mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1859
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IVA AXILLARIS POLLEN (UNII: 13KFG30UBR) (IVA AXILLARIS POLLEN - UNII:13KFG30UBR)	IVA AXILLARIS POLLEN	0.05 g  in 1 mL
IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22)	IVA ANNUA POLLEN	0.05 g  in 1 mL
CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (CYCLACHAENA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J)	CYCLACHAENA XANTHIFOLIA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1859-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, WEED MIX 2630 
weed mix 2630 injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2630
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (XANTHIUM STRUMARIUM POLLEN - UNII:2QOF601J1M)	XANTHIUM STRUMARIUM POLLEN	0.05 g  in 1 mL
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN)	CHENOPODIUM ALBUM POLLEN	0.05 g  in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW)	AMARANTHUS RETROFLEXUS POLLEN	0.05 g  in 1 mL
RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G)	RUMEX CRISPUS POLLEN	0.025 g  in 1 mL
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW)	RUMEX ACETOSELLA POLLEN	0.025 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2630-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, YEAST, BAKER SACCHAROMYCES CEREVISIAE 
yeast, baker saccharomyces cerevisiae injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-3714
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
YEAST (UNII: 3NY3SM6B8U) (YEAST - UNII:3NY3SM6B8U)	YEAST	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-3714-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, YEAST, BREWER SACCHAROMYCES CEREVISIAE 
yeast, brewer saccharomyces cerevisiae injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-3717
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
YEAST (UNII: 3NY3SM6B8U) (YEAST - UNII:3NY3SM6B8U)	YEAST	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-3717-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

INSECTS WHOLE BODY COCKROACH MIX 
insects whole body cockroach mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-6585
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089)	PERIPLANETA AMERICANA	0.1 g  in 1 mL
BLATTELLA GERMANICA (UNII: G9O67I0A8Q) (BLATTELLA GERMANICA - UNII:G9O67I0A8Q)	BLATTELLA GERMANICA	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-6585-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

INSECTS WHOLE BODY, ANT, FIRE SOLENOPSIS INVICTA 
ant, fire solenopsis invicta injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-6513
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SOLENOPSIS INVICTA (UNII: 5O7CR4P444) (SOLENOPSIS INVICTA - UNII:5O7CR4P444)	SOLENOPSIS INVICTA	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-6513-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

INSECTS WHOLE BODY, ANT, FIRE SOLENOPSIS RICHTERI 
ant, fire solenopsis richteri injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-6514
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SOLENOPSIS RICHTERI (UNII: 739684T11W) (SOLENOPSIS RICHTERI - UNII:739684T11W)	SOLENOPSIS RICHTERI	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-6514-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941	06/29/2018

INSECTS WHOLE BODY, FIRE ANT MIX 
insects whole body, fire ant mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-6515
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SOLENOPSIS RICHTERI (UNII: 739684T11W) (SOLENOPSIS RICHTERI - UNII:739684T11W)	SOLENOPSIS RICHTERI	0.1 g  in 1 mL
SOLENOPSIS INVICTA (UNII: 5O7CR4P444) (SOLENOPSIS INVICTA - UNII:5O7CR4P444)	SOLENOPSIS INVICTA	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-6515-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS - ALTERNARIA/HORMODENDRUM MIX 
molds - alternaria/hormodendrum mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5003
Route of Administration	PERCUTANEOUS

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
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO)	CLADOSPORIUM CLADOSPORIOIDES	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5003-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS - MOLD MIX 10 
molds - mold mix 10 injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5137
Route of Administration	PERCUTANEOUS

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
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48)	ASPERGILLUS FUMIGATUS	0.025 g  in 1 mL
ASPERGILLUS NIDULANS (UNII: 242A53RB80) (ASPERGILLUS NIDULANS - UNII:242A53RB80)	ASPERGILLUS NIDULANS	0.025 g  in 1 mL
ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6)	ASPERGILLUS NIGER VAR. NIGER	0.025 g  in 1 mL
ASPERGILLUS TERREUS (UNII: QBN8K7055X) (ASPERGILLUS TERREUS - UNII:QBN8K7055X)	ASPERGILLUS TERREUS	0.025 g  in 1 mL
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ)	FUSARIUM OXYSPORUM VASINFECTUM	0.1 g  in 1 mL
DENDRYPHIELLA VINOSA (UNII: 7S6NW5FH8X) (DENDRYPHIELLA VINOSA - UNII:7S6NW5FH8X)	DENDRYPHIELLA VINOSA	0.1 g  in 1 mL
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO)	CLADOSPORIUM CLADOSPORIOIDES	0.1 g  in 1 mL
MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G)	MUCOR RACEMOSUS	0.1 g  in 1 mL
PENICILLIUM DIGITATUM (UNII: 1SB49SV239) (PENICILLIUM DIGITATUM - UNII:1SB49SV239)	PENICILLIUM DIGITATUM	0.02 g  in 1 mL
PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z)	PENICILLIUM EXPANSUM	0.04 g  in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG)	PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM	0.02 g  in 1 mL
CLONOSTACHYS ROSEA F. ROSEA (UNII: I5F729WZ2H) (CLONOSTACHYS ROSEA F. ROSEA - UNII:I5F729WZ2H)	CLONOSTACHYS ROSEA F. ROSEA	0.02 g  in 1 mL
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M)	PHOMA EXIGUA VAR. EXIGUA	0.1 g  in 1 mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK)	AUREOBASIDIUM PULLULANS VAR. PULLUTANS	0.1 g  in 1 mL
RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q)	RHIZOPUS STOLONIFER	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5137-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS - MOLD MIX 4 
molds - mold mix 4 injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5002
Route of Administration	PERCUTANEOUS

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
ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48)	ASPERGILLUS FUMIGATUS	0.025 g  in 1 mL
ASPERGILLUS NIDULANS (UNII: 242A53RB80) (ASPERGILLUS NIDULANS - UNII:242A53RB80)	ASPERGILLUS NIDULANS	0.025 g  in 1 mL
ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6)	ASPERGILLUS NIGER VAR. NIGER	0.025 g  in 1 mL
ASPERGILLUS TERREUS (UNII: QBN8K7055X) (ASPERGILLUS TERREUS - UNII:QBN8K7055X)	ASPERGILLUS TERREUS	0.025 g  in 1 mL
CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO)	CLADOSPORIUM CLADOSPORIOIDES	0.1 g  in 1 mL
PENICILLIUM DIGITATUM (UNII: 1SB49SV239) (PENICILLIUM DIGITATUM - UNII:1SB49SV239)	PENICILLIUM DIGITATUM	0.025 g  in 1 mL
PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z)	PENICILLIUM EXPANSUM	0.05 g  in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG)	PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM	0.025 g  in 1 mL
CLONOSTACHYS ROSEA F. ROSEA (UNII: I5F729WZ2H) (CLONOSTACHYS ROSEA F. ROSEA - UNII:I5F729WZ2H)	CLONOSTACHYS ROSEA F. ROSEA	0.025 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5002-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS - TRICHOPHYTON MIX 
molds - trichophyton mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5285
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICHOPHYTON TONSURANS (UNII: JY1BE33I3Y) (TRICHOPHYTON TONSURANS - UNII:JY1BE33I3Y)	TRICHOPHYTON TONSURANS	0.1 g  in 1 mL
TRICHOPHYTON RUBRUM (UNII: 2ZAU32517N) (TRICHOPHYTON RUBRUM - UNII:2ZAU32517N)	TRICHOPHYTON RUBRUM	0.1 g  in 1 mL
TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV)	TRICHOPHYTON MENTAGROPHYTES	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5285-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, PENICILLIUM MIX 
molds, penicillium mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5169
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PENICILLIUM DIGITATUM (UNII: 1SB49SV239) (PENICILLIUM DIGITATUM - UNII:1SB49SV239)	PENICILLIUM DIGITATUM	0.1 g  in 1 mL
PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z)	PENICILLIUM EXPANSUM	0.2 g  in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG)	PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM	0.1 g  in 1 mL
CLONOSTACHYS ROSEA F. ROSEA (UNII: I5F729WZ2H) (CLONOSTACHYS ROSEA F. ROSEA - UNII:I5F729WZ2H)	CLONOSTACHYS ROSEA F. ROSEA	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5169-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, ALTERNARIA TENUIS 
alternaria tenuis injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5009
Route of Administration	PERCUTANEOUS

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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5009-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, ASPERGILLUS FUMIGATUS 
aspergillus fumigatus injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5021
Route of Administration	PERCUTANEOUS

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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5021-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, ASPERGILLUS NIGER 
aspergillus niger injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5033
Route of Administration	PERCUTANEOUS

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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5033-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, BOTRYTIS CINEREA 
botrytis cinerea injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5049
Route of Administration	PERCUTANEOUS

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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5049-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, CANDIDA ALBICANS 
candida albicans injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5053
Route of Administration	PERCUTANEOUS

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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5053-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, CEPHALOSPORIUM ACREMONIUM 
cephalosporium acremonium injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5057
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W)	SAROCLADIUM STRICTUM	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5057-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, CURVULARIA SPICIFERA 
curvularia spicifera injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5077
Route of Administration	PERCUTANEOUS

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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5077-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, EPICOCCUM NIGRUM 
epicoccum nigrum injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5101
Route of Administration	PERCUTANEOUS

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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5101-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, EPIDERMOPHYTON FLOCCOSUM 
epidermophyton floccosum injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5105
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPIDERMOPHYTON FLOCCOSUM (UNII: 6JR6JTN25S) (EPIDERMOPHYTON FLOCCOSUM - UNII:6JR6JTN25S)	EPIDERMOPHYTON FLOCCOSUM	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5105-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, FUSARIUM VASINFECTUM 
fusarium vasinfectum injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5113
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ)	FUSARIUM OXYSPORUM VASINFECTUM	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5113-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, HELMINTHOSPORIUM INTERSEMINATUM 
helminthosporium interseminatum injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5125
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DENDRYPHIELLA VINOSA (UNII: 7S6NW5FH8X) (DENDRYPHIELLA VINOSA - UNII:7S6NW5FH8X)	DENDRYPHIELLA VINOSA	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5125-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, HORMODENDRUM CLADOSPORIOIDES 
hormodendrum cladosporioides injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5129
Route of Administration	PERCUTANEOUS

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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5129-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, MUCOR RACEMOSUS 
mucor racemosus injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5145
Route of Administration	PERCUTANEOUS

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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5145-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, PENICILLIUM NOTATUM 
penicillium notatum injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5209
Route of Administration	PERCUTANEOUS

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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5209-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, PHOMA HERBARUM 
phoma herbarum injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5221
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M)	PHOMA EXIGUA VAR. EXIGUA	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5221-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, PULLULARIA PULLULANS 
pullularia pullulans injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5233
Route of Administration	PERCUTANEOUS

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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5233-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, RHIZOPUS NIGRICANS 
rhizopus nigricans injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5232
Route of Administration	PERCUTANEOUS

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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5232-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, STEMPHYLIUM BOTRYOSUM 
stemphylium botryosum injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-5265
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PLEOSPORA TARDA (UNII: TPL549N9R8) (PLEOSPORA TARDA - UNII:TPL549N9R8)	PLEOSPORA TARDA	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-5265-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - GRASSES, BAHIA GRASS PASPALUM NOTATUM 
bahia grass paspalum notatum injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1082
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK)	PASPALUM NOTATUM POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1082-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - GRASSES, BROME, SMOOTH BROMUS INERMIS 
brome, smooth bromus inermis injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1238
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6)	BROMUS INERMIS POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1238-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - GRASSES, CORN, CULTIVATED ZEA MAYS 
corn, cultivated zea mays injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1415
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H)	ZEA MAYS POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1415-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - GRASSES, JOHNSON GRASS SORGHUM HALEPENSE 
johnson grass sorghum halepense injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1745
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP)	SORGHUM HALEPENSE POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1745-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - GRASSES, OATS, COMMON, CULTIVATED AVENA SATIVA 
oats, common, cultivated avena sativa injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2042
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVENA SATIVA POLLEN (UNII: A7IKY24TR7) (AVENA SATIVA POLLEN - UNII:A7IKY24TR7)	AVENA SATIVA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2042-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - GRASSES, SOUTHERN GRASS MIX 
pollens - grasses, southern grass mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-0855
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T)	POA PRATENSIS POLLEN	100000 [BAU]  in 1 mL
DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P)	DACTYLIS GLOMERATA POLLEN	100000 [BAU]  in 1 mL
AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA) (AGROSTIS GIGANTEA POLLEN - UNII:HU8V6E7HOA)	AGROSTIS GIGANTEA POLLEN	100000 [BAU]  in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG)	PHLEUM PRATENSE POLLEN	100000 [BAU]  in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y)	ANTHOXANTHUM ODORATUM POLLEN	100000 [BAU]  in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP)	SORGHUM HALEPENSE POLLEN	0.05 g  in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10)	CYNODON DACTYLON POLLEN	10000 [BAU]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-0855-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - GRASSES, SOUTHERN GRASS MIX 
pollens - grasses, southern grass mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-0857
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T)	POA PRATENSIS POLLEN	10000 [BAU]  in 1 mL
DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P)	DACTYLIS GLOMERATA POLLEN	10000 [BAU]  in 1 mL
AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA) (AGROSTIS GIGANTEA POLLEN - UNII:HU8V6E7HOA)	AGROSTIS GIGANTEA POLLEN	10000 [BAU]  in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG)	PHLEUM PRATENSE POLLEN	10000 [BAU]  in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y)	ANTHOXANTHUM ODORATUM POLLEN	10000 [BAU]  in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP)	SORGHUM HALEPENSE POLLEN	0.005 g  in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10)	CYNODON DACTYLON POLLEN	1000 [BAU]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-0857-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, ACACIA ACACIA LONGIFOLIA 
acacia longifolia injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1007
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACACIA LONGIFOLIA POLLEN (UNII: 24SO2J296O) (ACACIA LONGIFOLIA POLLEN - UNII:24SO2J296O)	ACACIA LONGIFOLIA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1007-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, ALDER, RED ALNUS RUBRA 
alder, red alnus rubra injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1019
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALNUS RUBRA POLLEN (UNII: Z0F2YK1B7H) (ALNUS RUBRA POLLEN - UNII:Z0F2YK1B7H)	ALNUS RUBRA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1019-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, ASH, WHITE FRAXINUS AMERICANA 
ash, white fraxinus americana injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1061
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q)	FRAXINUS AMERICANA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1061-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, BEECH, AMERICAN FAGUS GRANDIFOLIA 
beech, american fagus grandifolia injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1121
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4)	FAGUS GRANDIFOLIA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1121-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, BIRCH MIX 
birch mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1169
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY) (BETULA PAPYRIFERA POLLEN - UNII:3538FNV8AY)	BETULA PAPYRIFERA POLLEN	0.05 g  in 1 mL
BETULA PENDULA POLLEN (UNII: ZL5TV40C5Y) (BETULA PENDULA POLLEN - UNII:ZL5TV40C5Y)	BETULA PENDULA POLLEN	0.05 g  in 1 mL
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P)	BETULA NIGRA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1169-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, BOTTLEBRUSH, CALLISTEMON SPP. 
bottlebrush, callistemon citrinus injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1208
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MELALEUCA CITRINA POLLEN (UNII: 62OII98F1T) (MELALEUCA CITRINA POLLEN - UNII:62OII98F1T)	MELALEUCA CITRINA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1208-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, BOXELDER/MAPLE MIX 
boxelder/maple mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1214
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V)	ACER NEGUNDO POLLEN	0.05 g  in 1 mL
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861)	ACER SACCHARUM POLLEN	0.05 g  in 1 mL
ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76)	ACER RUBRUM POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1214-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, CEDAR, MOUNTAIN JUNIPERUS ASHEI 
cedar, mountain juniperus ashei injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1337
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y)	JUNIPERUS ASHEI POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1337-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, CEDAR, RED JUNIPERUS VIRGINIANA 
cedar, red juniperus virginiana injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1340
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G)	JUNIPERUS VIRGINIANA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1340-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, COTTONWOOD, COMMON POPULUS DELTOIDES 
cottonwood, common populus deltoides injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1436
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP)	POPULUS DELTOIDES POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1436-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, CYPRESS, ARIZONA CUPRESSUS ARIZONICA 
cypress, arizona cupressus arizonica injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1451
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF) (CUPRESSUS ARIZONICA POLLEN - UNII:232DMH0XVF)	CUPRESSUS ARIZONICA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1451-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, CYPRESS, BALD TAXODIUM DISTICHUM 
cypress, bald taxodium distichum injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1454
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (TAXODIUM DISTICHUM POLLEN - UNII:O12H03B41R)	TAXODIUM DISTICHUM POLLEN	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1454-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, ELM, AMERICAN ULMUS AMERICANA 
elm, american ulmus americana injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1541
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD)	ULMUS AMERICANA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1541-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, ELM, CHINESE ULMUS PARVIFOLIA 
elm, chinese ulmus parvifolia injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1547
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ULMUS PARVIFOLIA POLLEN (UNII: IU0Z41653U) (ULMUS PARVIFOLIA POLLEN - UNII:IU0Z41653U)	ULMUS PARVIFOLIA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1547-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, EUCALYPTUS, EUCALYPTUS GLOBULUS 
eucalyptus globulus injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1565
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9)	EUCALYPTUS GLOBULUS POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1565-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, GUM, SWEET LIQUIDAMBAR STYRACIFLUA 
gum, sweet liquidambar styraciflua injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1661
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS)	LIQUIDAMBAR STYRACIFLUA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1661-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, HACKBERRY CELTIS OCCIDENTALIS 
hackberry celtis occidentalis injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1664
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X)	CELTIS OCCIDENTALIS POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1664-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, HICKORY, SHAGBARK CARYA OVATA 
hickory, shagbark carya ovata injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1703
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARYA OVATA POLLEN (UNII: 54UN9R2798) (CARYA OVATA POLLEN - UNII:54UN9R2798)	CARYA OVATA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1703-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, LINDEN BASSWOOD TILIA AMERICANA 
linden basswood tilia americana injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1802
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TILIA AMERICANA POLLEN (UNII: E2B4Q4BXJG) (TILIA AMERICANA POLLEN - UNII:E2B4Q4BXJG)	TILIA AMERICANA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1802-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941	05/21/2016

POLLENS - TREES, MAPLE, HARD ACER SACCHARUM 
maple, hard acer saccharum injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1832
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861)	ACER SACCHARUM POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1832-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, MELALEUCA PUNK TREE MELALEUCA QUINQUENERVIA 
melaleuca, melaleuca quinquenervia injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1874
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E)	MELALEUCA QUINQUENERVIA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1874-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, MESQUITE, PROSOPIS JULIFLORA 
mesquite, prosopis juliflora injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1877
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (PROSOPIS JULIFLORA POLLEN - UNII:6EIJ3D04MR)	PROSOPIS JULIFLORA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1877-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, MULBERRY MIX 
mulberry mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1910
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H)	MORUS ALBA POLLEN	0.05 g  in 1 mL
MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52)	MORUS RUBRA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1910-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, OAK MIX 
oak mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2036
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C)	QUERCUS RUBRA POLLEN	0.05 g  in 1 mL
QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO)	QUERCUS VIRGINIANA POLLEN	0.05 g  in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK)	QUERCUS ALBA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2036-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, OAK, RED QUERCUS RUBRA 
oak, red quercus rubra injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2015
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C)	QUERCUS RUBRA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2015-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, OLIVE OLEA EUROPAEA 
olive olea europaea injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2051
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (OLEA EUROPAEA POLLEN - UNII:43R41XZ627)	OLEA EUROPAEA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2051-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, OLIVE, RUSSIAN ELAEAGNUS ANGUSTIFOLIA 
russian olive elaeagnus angustifolia injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2360
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ELAEAGNUS ANGUSTIFOLIA POLLEN (UNII: 68P4F4M6VD) (ELAEAGNUS ANGUSTIFOLIA POLLEN - UNII:68P4F4M6VD)	ELAEAGNUS ANGUSTIFOLIA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2360-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, PALM, QUEEN COCOS PLUMOSA 
palm, queen cocos plumosa injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2075
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB) (SYAGRUS ROMANZOFFIANA POLLEN - UNII:84ZOM591BB)	SYAGRUS ROMANZOFFIANA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2075-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, PALO VERDE CERCIDIUM FLORIDUM 
palo verde cercidium floridum injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2017
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PARKINSONIA FLORIDA POLLEN (UNII: 57586C96ZL) (PARKINSONIA FLORIDA POLLEN - UNII:57586C96ZL)	PARKINSONIA FLORIDA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2017-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, PECAN CARYA CARYA ILLINOENSIS 
pecan carya carya illinoensis injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2099
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y)	CARYA ILLINOINENSIS POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2099-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, PEPPER TREE, CALIFORNIA SCHINUS MOLLE 
pepper tree, california schinus molle injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2108
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SCHINUS MOLLE POLLEN (UNII: M0G28FH9K1) (SCHINUS MOLLE POLLEN - UNII:M0G28FH9K1)	SCHINUS MOLLE POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2108-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, PINE MIX 
pine mix injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2204
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PINUS CONTORTA POLLEN (UNII: FB7IP650ET) (PINUS CONTORTA POLLEN - UNII:FB7IP650ET)	PINUS CONTORTA POLLEN	0.05 g  in 1 mL
PINUS PONDEROSA POLLEN (UNII: 042SUA2DS9) (PINUS PONDEROSA POLLEN - UNII:042SUA2DS9)	PINUS PONDEROSA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2204-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, PRIVET LIGUSTRUM VULGARE 
privet ligustrum vulgare injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2252
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E)	LIGUSTRUM VULGARE POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2252-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, SYCAMORE, AMERICAN EASTERN PLATANUS OCCIDENTALLIS 
sycamore, american eastern platanus occidentallis injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2564
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK)	PLATANUS OCCIDENTALIS POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2564-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, TREE MIX 11 
tree mix 11 injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2620
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q)	FRAXINUS AMERICANA POLLEN	0.05 g  in 1 mL
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P)	BETULA NIGRA POLLEN	0.05 g  in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR)	JUGLANS NIGRA POLLEN	0.05 g  in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP)	POPULUS DELTOIDES POLLEN	0.05 g  in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD)	ULMUS AMERICANA POLLEN	0.05 g  in 1 mL
CARYA OVATA POLLEN (UNII: 54UN9R2798) (CARYA OVATA POLLEN - UNII:54UN9R2798)	CARYA OVATA POLLEN	0.05 g  in 1 mL
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861)	ACER SACCHARUM POLLEN	0.05 g  in 1 mL
QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C)	QUERCUS RUBRA POLLEN	0.05 g  in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK)	PLATANUS OCCIDENTALIS POLLEN	0.05 g  in 1 mL
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN)	SALIX NIGRA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2620-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, TREE MIX 5 
tree mix 5 injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2858
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y)	CARYA ILLINOINENSIS POLLEN	0.05 g  in 1 mL
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861)	ACER SACCHARUM POLLEN	0.017 g  in 1 mL
ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V)	ACER NEGUNDO POLLEN	0.017 g  in 1 mL
ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76)	ACER RUBRUM POLLEN	0.017 g  in 1 mL
QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C)	QUERCUS RUBRA POLLEN	0.017 g  in 1 mL
QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO)	QUERCUS VIRGINIANA POLLEN	0.017 g  in 1 mL
QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK)	QUERCUS ALBA POLLEN	0.017 g  in 1 mL
PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK)	PLATANUS OCCIDENTALIS POLLEN	0.05 g  in 1 mL
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN)	SALIX NIGRA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2858-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, TREE MIX 6 
tree mix 6 injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2859
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q)	FRAXINUS AMERICANA POLLEN	0.05 g  in 1 mL
BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY) (BETULA PAPYRIFERA POLLEN - UNII:3538FNV8AY)	BETULA PAPYRIFERA POLLEN	0.017 g  in 1 mL
BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P)	BETULA NIGRA POLLEN	0.017 g  in 1 mL
BETULA PENDULA POLLEN (UNII: ZL5TV40C5Y) (BETULA PENDULA POLLEN - UNII:ZL5TV40C5Y)	BETULA PENDULA POLLEN	0.017 g  in 1 mL
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR)	JUGLANS NIGRA POLLEN	0.05 g  in 1 mL
POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP)	POPULUS DELTOIDES POLLEN	0.05 g  in 1 mL
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD)	ULMUS AMERICANA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2859-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, TREE OF HEAVEN AILANTHUS ALTISSIMA 
tree of heaven ailanthus altissima injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2600
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3) (AILANTHUS ALTISSIMA POLLEN - UNII:2A64U81OQ3)	AILANTHUS ALTISSIMA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2600-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, WALNUT, BLACK JUGLANS NIGRA 
walnut, black juglans nigra injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2627
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR)	JUGLANS NIGRA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2627-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, WILLOW, BLACK SALIX NIGRA 
willow, black salix nigra injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2678
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN)	SALIX NIGRA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2678-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, COCKLEBUR XANTHIUM STRUMARIUM 
cocklebur xanthium strumarium injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1406
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (XANTHIUM STRUMARIUM POLLEN - UNII:2QOF601J1M)	XANTHIUM STRUMARIUM POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1406-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, DOG FENNEL EUPATORIUM CAPILLIFOLIUM 
dog fennel eupatorium capillifolium injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2058
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0) (EUPATORIUM CAPILLIFOLIUM POLLEN - UNII:B67NF86HF0)	EUPATORIUM CAPILLIFOLIUM POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2058-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, GOLDENROD SOLIDAGO CANADENSIS 
goldenrod solidago canadensis injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1631
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5)	SOLIDAGO CANADENSIS POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1631-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, LAMBS QUARTERS CHENOPODIUM ALBUM 
lambs quarters chenopodium album injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1787
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN)	CHENOPODIUM ALBUM POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1787-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, NETTLE URTICA DIOICA 
nettle urtica dioica injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-1946
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
URTICA DIOICA POLLEN (UNII: DNB59M1NVU) (URTICA DIOICA POLLEN - UNII:DNB59M1NVU)	URTICA DIOICA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-1946-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, PIGWEED, ROUGH REDROOT AMARANTHUS RETROFLEXUS 
pigweed, rough redroot amaranthus retroflexus injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2126
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW)	AMARANTHUS RETROFLEXUS POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2126-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, PLANTAIN, ENGLISH PLANTAGO LANCEOLATA 
plantain, english plantago lanceolata injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2213
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI)	PLANTAGO LANCEOLATA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2213-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, GIANT AMBROSIA TRIFIDA 
ragweed, giant ambrosia trifida injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2294
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX)	AMBROSIA TRIFIDA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2294-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED. WESTERN AMBROSIA PSILOSTACHYA 
ragweed. western ambrosia psilostachya injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2309
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L)	AMBROSIA PSILOSTACHYA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2309-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, RUSSIAN THISTLE SALSOLA KALI 
russian thistle salsola kali injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2363
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G)	SALSOLA KALI POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2363-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, SAGEBRUSH, MUGWORT ARTEMISIA VULGARIS 
sagebrush, mugwort artemisia vulgaris injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2414
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D)	ARTEMISIA VULGARIS POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2414-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, SCALE, WING SHAD ATRIPLEX CANESCENS 
scale, wing shad atriplex canescens injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2483
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATRIPLEX CANESCENS POLLEN (UNII: 26U0BU8G83) (ATRIPLEX CANESCENS POLLEN - UNII:26U0BU8G83)	ATRIPLEX CANESCENS POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2483-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, SCOTCH BROOM CYTISUS SCOPARIUS 
scotch broom cytisus scoparius injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2486
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYTISUS SCOPARIUS FLOWERING TOP (UNII: XZC6H8R666) (CYTISUS SCOPARIUS FLOWERING TOP - UNII:XZC6H8R666)	CYTISUS SCOPARIUS FLOWERING TOP	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2486-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, SORREL, SHEEP RUMEX ACETOSELLA 
sorrel, sheep rumex acetosella injection, solution

Product Information
Product Type	NON-STANDARDIZED ALLERGENIC	Item Code (Source)	NDC: 65044-2507
Route of Administration	PERCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW)	RUMEX ACETOSELLA POLLEN	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65044-2507-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

Labeler - Jubilant HollisterStier LLC (069263643)

Registrant - Jubilant HollisterStier LLC (069263643)