Mometasone furoate lotion (mometasone furoate topical solution 0.1%) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.
Apply a few drops of mometasone furoate lotion (mometasone furoate topical solution 0.1%) to the affected skin areas once daily and massage lightly until it disappears. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] . Do not use mometasone furoat...
Mometasone furoate lotion (mometasone furoate topical solution USP, 0.1%) is supplied in: NDC 0168-0272-30, 30 mL (27.5 g) NDC 0168-0272-60, 60 mL (55 g) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
www.fda.gov/medwatchMometasone furoate lotion (mometasone furoate topical solution 0.1%) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.
Apply a few drops of mometasone furoate lotion (mometasone furoate topical solution 0.1%) to the affected skin areas once daily and massage lightly until it disappears.
Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
Do not use mometasone furoate lotion (mometasone furoate topical solution 0.1%) with occlusive dressings unless directed by a physician. Do not apply mometasone furoate lotion (mometasone furoate topical solution 0.1%) in the diaper area if the patient requires diapers or plastic pants, as these garments constitute occlusive dressing.
Mometasone furoate lotion (mometasone furoate topical solution 0.1%) is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Avoid use on the face, groin, or axillae. Avoid contact with eyes. Wash hands after each application.
Lotion, 0.1%. Each gram of mometasone furoate lotion (mometasone furoate topical solution USP, 0.1%) contains 1 mg of mometasone furoate, USP in a colorless, clear lotion base.
Mometasone furoate lotion (mometasone furoate topical solution 0.1%) is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure and young age.
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.
In a study evaluating the effects of mometasone furoate lotion on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to 4 adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the 4 subjects remained within the normal range and changed little from baseline.
If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) ].
Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products, including the topical mometasone products [see Adverse Reactions (6.2)].
Avoid contact of mometasone furoate lotion (mometasone furoate topical solution 0.1%) with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
If irritation develops, mometasone furoate lotion (mometasone furoate topical solution 0.1%) should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of mometasone furoate lotion (mometasone furoate topical solution 0.1%) should be discontinued until the infection has been adequately controlled.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In clinical trials involving 209 subjects, the incidence of adverse reactions associated with the use of mometasone furoate lotion (mometasone furoate topical solution 0.1%) was 3%. Reported reactions included acneiform reaction, 2; burning, 4; and itching, 1. In an irritation/sensitization study involving 156 normal subjects, the incidence of folliculitis was 3% (4 subjects).
The following adverse reactions were reported to be possibly or probably related to treatment with mometasone furoate lotion (mometasone furoate topical solution 0.1%) during a clinical trial in 14% of 65 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 4; paresthesia, 2; dry mouth,1; an unspecified endocrine disorder, 1; pruritus, 1; and an unspecified skin disorder, 1. The following signs of skin atrophy were also observed among 65 subjects treated with mometasone furoate lotion (mometasone furoate topical solution 0.1%) in a clinical trial: shininess, 4; telangiectasia, 2; loss of elasticity, 2; and loss of normal skin markings, 3.
Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Postmarketing reports for local adverse reactions to topical corticosteroids include irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. These adverse reactions may occur more frequently with the use of occlusive dressings.
Postmarketing reports for ophthalmic adverse reactions to topical corticosteroids include blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.
No drug-drug interaction studies have been conducted with mometasone furoate lotion (mometasone furoate topical solution 0.1%).
Teratogenic Effects, Pregnancy Category C:
There are no adequate and well-controlled studies in pregnant women. Therefore, mometasone furoate lotion (mometasone furoate topical solution 0.1%) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy.
In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on a mcg/m2 basis.)
In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on a mcg/m2 basis.)
In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on a mcg/m2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2,800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2,800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on a mcg/m2 basis.)
When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on a mcg/m2 basis.)
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when mometasone furoate lotion (mometasone furoate topical solution 0.1%) is administered to a nursing woman.
Since safety and efficacy of mometasone furoate lotion (mometasone furoate topical solution 0.1%) have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended.
Mometasone furoate lotion (mometasone furoate topical solution 0.1%) caused HPA axis suppression in approximately 29% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 40% (range 16% to 90%). The criteria for suppression were: basal cortisol level of ≤ 5 mcg/dL, 30-minute post-stimulation level of ≤ 18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population [see Clinical Pharmacology (12.2) ].
Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Mometasone furoate lotion (mometasone furoate topical solution 0.1%) should not be used in the treatment of diaper dermatitis.
Clinical trials of mometasone furoate lotion (mometasone furoate topical solution 0.1%) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range.
Topically applied mometasone furoate lotion (mometasone furoate topical solution 0.1%) can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1) ].
Mometasone furoate lotion (mometasone furoate topical solution USP, 0.1%) contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity.
Chemically, mometasone furoate is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the molecular formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula:
Mometasone furoate,USP is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.
Each gram of mometasone furoate lotion (mometasone furoate topical solution USP, 0.1%) contains 1 mg mometasone furoate, USP in a colorless, clear lotion base of isopropyl alcohol (40%), propylene glycol, hydroxypropyl cellulose, monobasic sodium phosphate (monohydrate) and purified water. May also contain phosphoric acid used to adjust the pH to approximately 4.5.
Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Studies performed with mometasone furoate lotion (mometasone furoate topical solution 0.1%) indicate that it is in the medium range of potency as compared with other topical corticosteroids.
In a study evaluating the effects of mometasone furoate lotion (mometasone furoate topical solution 0.1%) on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to 4 adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the 4 subjects remained within the normal range and changed little from baseline [see Warnings and Precautions (5.1)].
Sixty-five pediatric subjects ages 6 to 23 months, with atopic dermatitis, were enrolled in an open-label, HPA axis safety trial. Mometasone furoate lotion (mometasone furoate topical solution 0.1%) was applied once daily for approximately 3 weeks over a mean body surface area of 40% (range 16% to 90%). In approximately 29% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with mometasone furoate lotion (mometasone furoate topical solution, 0.1%). The criteria for suppression were: basal cortisol level of ≤ 5 mcg/dL, 30-minute post-stimulation level of ≤ 18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria [see Use in Specific Populations (8.4)].
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0.7% of the applied dose of mometasone furoate lotion (mometasone furoate topical solution 0.1%) enters the circulation after 8 hours of contact on normal skin without occlusion. A similar minimal degree of absorption of the corticosteroid from the lotion formulation would be anticipated. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Long-term animal studies have not been performed to evaluate the carcinogenic potential of mometasone furoate lotion (mometasone furoate topical solution 0.1%). Long-term carcinogenicity studies of mometasone furoate were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on a mcg/m2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on a mcg/m2 basis).
Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.
In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from mometasone furoate lotion (mometasone furoate topical solution 0.1%) on a mcg/m2 basis).
The safety and efficacy of mometasone furoate lotion (mometasone furoate topical solution 0.1%) for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle-controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. A total of 405 subjects (age range: 12 to 95 years) received mometasone furoate lotion (mometasone furoate topical solution 0.1%) (205 subjects) or the vehicle lotion applied once daily for 21 days.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform patients of the following:
Mometasone Furoate Lotion (Mometasone Furoate Topical Solution, USP 0.1%)
(moe-MEH-tah-zone)
Important information: Mometasone furoate lotion (mometasone furoate topical solution 0.1%) is for use on skin only. Do not use mometasone furoate lotion (mometasone furoate topical solution 0.1%) in your eyes, mouth, or vagina. |
What is mometasone furoate lotion (mometasone furoate topical solution 0.1%)?
|
Do not use mometasone furoate lotion (mometasone furoate topical solution 0.1%) if you are allergic to mometasone furoate or any of the ingredients in mometasone furoate lotion (mometasone furoate topical solution 0.1%). See the end of this leaflet for a complete list of ingredients in mometasone furoate lotion (mometasone furoate topical solution 0.1%). |
Before usingmometasone furoate lotion (mometasone furoate topical solution 0.1%),tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids. |
How should I use mometasone furoate lotion (mometasone furoate topical solution 0.1%)?
|
What are the possible side effects of (mometasone furoate topical solution 0.1%)? Mometasone furoate lotion (mometasone furoate topical solution 0.1%)may cause serious side effects, including:
The most common side effects of mometasone furoate lotion (mometasone furoate topical solution 0.1%) include burning, itching, and inflammation of the hair follicle (folliculitis). These are not all the possible side effects of mometasone furoate lotion (mometasone furoate topical solution 0.1%). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store mometasone furoate lotion (mometasone furoate topical solution 0.1%)?
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General information about the safe and effective use of mometasone furoate lotion (mometasone furoate topical solution 0.1%). Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mometasone furoate lotion (mometasone furoate topical solution 0.1%) for a condition for which it was not prescribed. Do not give mometasone furoate lotion (mometasone furoate topical solution 0.1%) to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about mometasone furoate lotion (mometasone furoate topical solution 0.1%) that is written for health professionals. |
What are the ingredients in mometasone furoate lotion (mometasone furoate topical solution 0.1%)? Active ingredient: mometasone furoate, USP Inactive ingredients: isopropyl alcohol (40%), propylene glycol, hydroxypropyl cellulose, monobasic sodium phosphate (monohydrate) and purified water. May also contain phosphoric acid used to adjust the pH to approximately 4.5. |
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised 09/18
NDC 0168-0272-30
Fougera®
Mometasone Furoate
Topical Solution USP,
0.1% (Lotion)
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
Rx Only DO NOT USE IN EYES 30 mL
NDC 0168-0272-30
Fougera®
Mometasone
Furoate
Topical Solution
USP, 0.1% (Lotion)
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
Rx Only DO NOT USE IN EYES 30 mL
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0168-0272-30 | ML - Milliliter | 0168-0272 | 7b28f56e-ae2a-4fe5-b37c-5b3199cae13e | 1 | 2012-07-24 |
| 0168-0272-60 | ML - Milliliter | 0168-0272 | d2c3424c-fad5-4dc6-bc39-fec0ba9b749b | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MOMETASONE FUROATE | ACTIVE INGREDIENT | 04201GDN4R | 4 | |
| MOMETASONE | ACTIVE MOIETY | 8HR4QJ6DW8 | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | 4 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | 4 | |
| PHOSPHORIC ACID | INACTIVE INGREDIENT | E4GA8884NN | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 4 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0168-0272 | 0168-0272-30, 0168-0272-60 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MOMETASONE FUROATE | 04201GDN4R | ACTIB |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | IACT |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | IACT |
| WATER | 059QF0KO0R | IACT |
| PHOSPHORIC ACID | E4GA8884NN | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 2 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 15.55 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | SOLUTION/ DROPS / OPHTHALMIC | 8 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 6 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | CREAM / TOPICAL | 13 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 13.61 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION / INTRAVASCULAR | 0.15 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | INJECTION, SOLUTION / INTRAVENOUS | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, SUSPENSION / INTRASYNOVIAL | 13 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | SOLUTION / TOPICAL | 200 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | FILM, EXTENDED RELEASE / TRANSDERMAL | 19 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | CREAM / TOPICAL | 10 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / INTRAVENOUS | 5 %w/v | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | GEL, METERED / TOPICAL | 525 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION / INTRAVITREAL | 0.86 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | SUSPENSION / SUBCUTANEOUS | 0.07 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | TABLET, EXTENDED RELEASE / ORAL | 0.19 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, EXTENDED RELEASE / ORAL | 864 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 15.55 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | TABLET / ORAL | 31.72 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYSTEM / TOPICAL | 4200 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | INJECTION / INTRALESIONAL | ADJ PH | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | AEROSOL, FOAM / VAGINAL | NA | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION / INTRAVENOUS | 120 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, ORALLY DISINTEGRATING / ORAL | 4 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | SOLUTION / TOPICAL | 40 %w/v | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | GEL / TOPICAL | 75 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | CAPSULE / ORAL | 120 mg | ||
| HYDROXYPROPYL CELLULOSE (TYPE H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | LOTION, AUGMENTED / TOPICAL | 0.2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | TABLET, DELAYED RELEASE / ORAL | 35 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075919-001 | MOMETASONE FUROATE | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 |
| Application-product | TE code |
|---|---|
| A075919-001 | AB |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A075919-001 | MOMETASONE FUROATE | 0.1% | LOTION / TOPICAL | AB | 2007-11-29 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075919-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075919-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075919-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075919-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075919-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075919-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075919-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075919-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075919-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075919-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075919-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075919-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075919-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075919-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075919-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075919-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075919-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075919-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075919-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075919-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075919-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075919-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075919-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A075919-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A075919-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A075919-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A075919-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A075919-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A075919-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075919-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A075919-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A075919-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075919-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075919-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075919-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075919-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A075919-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A075919-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075919-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A075919-001 | AB | 1 | f41ea6bd6efb… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9f471046-9fd7-46a8-b8ea-67f11f98d9d6 | f0e34967-88f3-4956-b1f5-a0dff41942e9 | 2018-09-17 | Warnings, Adverse reactions | f0e34967-88f3-4956-b1f5-a0dff41942e9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.