Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019966
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TEMOVATE CLOBETASOL PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;TOPICAL Discontinued None Yes No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.

11/15/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/29/1994 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/23/1993 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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

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