Details for New Drug Application (NDA): 210208
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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 210208
Tradename: | CLOBETASOL PROPIONATE |
Applicant: | Lupin Ltd |
Ingredient: | clobetasol propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210208
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210208
Suppliers and Packaging for NDA: 210208
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | clobetasol propionate | CREAM;TOPICAL | 210208 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-956 | 68180-956-01 | 1 TUBE in 1 CARTON (68180-956-01) / 15 g in 1 TUBE |
CLOBETASOL PROPIONATE | clobetasol propionate | CREAM;TOPICAL | 210208 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-956 | 68180-956-02 | 1 TUBE in 1 CARTON (68180-956-02) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Jan 30, 2018 | TE: | AB1 | RLD: | No |
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