Details for New Drug Application (NDA): 078854
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The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 078854
Tradename: | CLOBETASOL PROPIONATE |
Applicant: | Actavis Mid Atlantic |
Ingredient: | clobetasol propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078854
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 078854
Suppliers and Packaging for NDA: 078854
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | clobetasol propionate | SHAMPOO;TOPICAL | 078854 | ANDA | Actavis Pharma, Inc. | 0472-0403 | 0472-0403-94 | 1 BOTTLE in 1 CARTON (0472-0403-94) / 118 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SHAMPOO;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Jun 7, 2011 | TE: | RLD: | No |
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