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Details for New Drug Application (NDA): 019966
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The generic ingredient in TEMOVATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 019966
Tradename: | TEMOVATE |
Applicant: | Fougera Pharms |
Ingredient: | clobetasol propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019966
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 019966
Suppliers and Packaging for NDA: 019966
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TEMOVATE | clobetasol propionate | SOLUTION;TOPICAL | 019966 | NDA | PharmaDerm, A division of Fougera Pharmaceuticals Inc. | 0462-0269 | 0462-0269-50 | 50 mL in 1 BOTTLE, PLASTIC (0462-0269-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;TOPICAL | Strength | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
Approval Date: | Feb 22, 1990 | TE: | RLD: | Yes |
Expired US Patents for NDA 019966
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Fougera Pharms | TEMOVATE | clobetasol propionate | SOLUTION;TOPICAL | 019966-001 | Feb 22, 1990 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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