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Details for New Drug Application (NDA): 019966
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NDA 019966 describes TEMOVATE, which is a drug marketed by Fougera Pharms and is included in five NDAs. Additional details are available on the TEMOVATE profile page.
The generic ingredient in TEMOVATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
The generic ingredient in TEMOVATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Fifty-four 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 |
Medical Subject Heading (MeSH) Categories for 019966
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| Dosage: | SOLUTION;TOPICAL | Strength | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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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