Details for New Drug Application (NDA): 209411
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NDA 209411 describes CLOBETASOL PROPIONATE (EMOLLIENT), which is a drug marketed by Ani Pharms, Beach Prods, Fougera Pharms, and Sun Pharma Canada, 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-three 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-three suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 209411
| Tradename: | CLOBETASOL PROPIONATE (EMOLLIENT) |
| Applicant: | Beach Prods |
| Ingredient: | clobetasol propionate |
| Patents: | 0 |
Pharmacology for NDA: 209411
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 209411
Suppliers and Packaging for NDA: 209411
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE (EMOLLIENT) | clobetasol propionate | CREAM;TOPICAL | 209411 | ANDA | The J. Molner Company LLC | 83148-064 | 83148-064-15 | 1 TUBE in 1 CARTON (83148-064-15) / 15 g in 1 TUBE |
| CLOBETASOL PROPIONATE (EMOLLIENT) | clobetasol propionate | CREAM;TOPICAL | 209411 | ANDA | The J. Molner Company LLC | 83148-064 | 83148-064-30 | 1 TUBE in 1 CARTON (83148-064-30) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Aug 21, 2017 | TE: | AB2 | RLD: | No | ||||
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