Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019966
Company: FOUGERA PHARMS

Products on NDA 019966

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TEMOVATE	CLOBETASOL PROPIONATE	0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019966

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.

Labels for NDA 019966

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