FOUGERA PHARMS Application 019966

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEMOVATE	CLOBETASOL PROPIONATE	SOLUTION;TOPICAL	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0462-0269	Temovate	Clobetasol Propionate	PharmaDerm, A division of Fougera Pharmaceuticals Inc.	NDA	Current

Document, Submission type, Date table
Document	Submission type	Date
1876	SUPPL	2003-04-18
12113	SUPPL	2003-04-07