Details for New Drug Application (NDA): 075391
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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 075391
Tradename: | CLOBETASOL PROPIONATE |
Applicant: | Fougera Pharms |
Ingredient: | clobetasol propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075391
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 075391
Suppliers and Packaging for NDA: 075391
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | clobetasol propionate | SOLUTION;TOPICAL | 075391 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0269 | 0168-0269-50 | 50 mL in 1 BOTTLE, PLASTIC (0168-0269-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Feb 8, 1999 | TE: | AT | RLD: | No |
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