Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020337
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| TEMOVATE | CLOBETASOL PROPIONATE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/29/1994 | 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 |
|---|---|---|---|---|---|
| 04/02/2003 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020337s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20337slr005ltr.pdf | |
| 06/05/1998 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/15/1996 | SUPPL-1 | Manufacturing (CMC) |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020337s001_temovate_toc.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/02/2003 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020337s005lbl.pdf |