Details for New Drug Application (NDA): 019323
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The generic ingredient in TEMOVATE 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 019323
Tradename: | TEMOVATE |
Applicant: | Fougera Pharms |
Ingredient: | clobetasol propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 019323
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | OINTMENT;TOPICAL | Strength | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 27, 1985 | TE: | RLD: | Yes |
Expired US Patents for NDA 019323
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Fougera Pharms | TEMOVATE | clobetasol propionate | OINTMENT;TOPICAL | 019323-001 | Dec 27, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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