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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020340
Company: FOUGERA PHARMS

Products on NDA 020340

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TEMOVATE E	CLOBETASOL PROPIONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020340

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.

Labels for NDA 020340

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

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