Details for New Drug Application (NDA): 201402
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The generic ingredient in CLOBETASOL PROPIONATE 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 201402
Tradename: | CLOBETASOL PROPIONATE |
Applicant: | Padagis Israel |
Ingredient: | clobetasol propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201402
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 201402
Suppliers and Packaging for NDA: 201402
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | clobetasol propionate | AEROSOL, FOAM;TOPICAL | 201402 | ANDA | Medimetriks Pharmaceuticals, Inc. | 43538-952 | 43538-952-10 | 1 CANISTER in 1 CARTON (43538-952-10) / 100 g in 1 CANISTER |
CLOBETASOL PROPIONATE | clobetasol propionate | AEROSOL, FOAM;TOPICAL | 201402 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-637 | 45802-637-32 | 1 CAN in 1 CARTON (45802-637-32) / 50 g in 1 CAN |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Aug 14, 2012 | TE: | AB2 | RLD: | No |
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