FOUGERA PHARMS Application 019828

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXISTAT	OXICONAZOLE NITRATE	CREAM;TOPICAL	EQ 1% BASE	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0358	Oxiconazole Nitrate	Oxiconazole Nitrate	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0168-0358	Oxiconazole Nitrate	Oxiconazole Nitrate	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
10337-358	Oxistat	oxiconazole nitrate	PharmaDerm a division of Fougera Pharmaceuticals Inc.	NDA	Current
10337-358	Oxistat	oxiconazole nitrate	PharmaDerm a division of Fougera Pharmaceuticals Inc.	NDA	Current

Document, Submission type, Date table
Document	Submission type	Date
33994	SUPPL	2004-02-02
19269	SUPPL	2004-01-29