Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020340
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEMOVATE E CLOBETASOL PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CREAM;TOPICAL Discontinued None Yes No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
06/17/1994 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
11/15/2012 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020340s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020340Orig1s007ltr.pdf
04/02/2003 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020340s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20340slr006ltr.pdf
08/08/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/15/1996 SUPPL-3 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020340s003_temovate_toc.cfm
07/24/1995 SUPPL-2 Labeling

Label is not available on this site.

05/03/1996 SUPPL-1 Efficacy-New Dosing Regimen

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2012 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020340s007lbl.pdf
04/02/2003 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020340s006lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English