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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019323
Company: FOUGERA PHARMS

Products on NDA 019323

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TEMOVATE	CLOBETASOL PROPIONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019323

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 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-19	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
06/01/1998	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
11/15/1996	SUPPL-16	Manufacturing (CMC)	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019323-S16_Temovate Ointment 0.05%_toc.cfm
06/29/1994	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
06/07/1994	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
08/23/1993	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
03/05/1993	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
08/30/1995	SUPPL-11	Labeling		Label is not available on this site.
04/17/1992	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/07/1989	SUPPL-8	Labeling		Label is not available on this site.
12/07/1989	SUPPL-7	Labeling		Label is not available on this site.
08/13/1987	SUPPL-6	Manufacturing (CMC)-Expiration Date		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.

Labels for NDA 019323

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2003	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019322s018lbl.pdf

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