Drugs@FDA: FDA-Approved Drugs
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TEMOVATE | CLOBETASOL PROPIONATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/27/1985 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019322Orig1s000rev.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/02/2003 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019322s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19322slr018,19323slr019ltr.pdf | |
08/08/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/15/1996 | SUPPL-15 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019322-S15_TemovateCream_toc.cfm |
06/29/1994 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/07/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/23/1993 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/05/1993 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/30/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
04/17/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/15/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
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12/07/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
12/07/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
03/03/1987 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/10/1987 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/09/1987 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/02/2003 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019322s018lbl.pdf |