Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019323
Company: FOUGERA

Products on NDA 19323

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TEMOVATE	CLOBETASOL PROPIONATE	0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	OINTMENT;TOPICAL	Discontinued	None	Yes	No

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