Details for New Drug Application (NDA): 075430
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NDA 075430 describes CLOBETASOL PROPIONATE (EMOLLIENT), which is a drug marketed by Ani Pharms, Beach Prods, Fougera Pharms, and Taro, and is included in four NDAs. It is available from three suppliers. Additional details are available on the CLOBETASOL PROPIONATE (EMOLLIENT) profile page.
The generic ingredient in CLOBETASOL PROPIONATE (EMOLLIENT) is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
The generic ingredient in CLOBETASOL PROPIONATE (EMOLLIENT) is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 075430
| Tradename: | CLOBETASOL PROPIONATE (EMOLLIENT) |
| Applicant: | Fougera Pharms |
| Ingredient: | clobetasol propionate |
| Patents: | 0 |
Pharmacology for NDA: 075430
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 075430
Suppliers and Packaging for NDA: 075430
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE (EMOLLIENT) | clobetasol propionate | CREAM;TOPICAL | 075430 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0301 | 0168-0301-15 | 1 TUBE in 1 CARTON (0168-0301-15) / 15 g in 1 TUBE |
| CLOBETASOL PROPIONATE (EMOLLIENT) | clobetasol propionate | CREAM;TOPICAL | 075430 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0301 | 0168-0301-30 | 1 TUBE in 1 CARTON (0168-0301-30) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | May 26, 1999 | TE: | AB2 | RLD: | No | ||||
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