Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019966
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TEMOVATE | CLOBETASOL PROPIONATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;TOPICAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/22/1990 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/03/2003 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019966s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19966slr008ltr.pdf | |
08/08/1997 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/15/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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06/29/1994 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/07/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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08/23/1993 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/17/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/03/2003 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019966s008lbl.pdf |