MEDICIS Application 050802

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZIANA	CLINDAMYCIN PHOSPHATE; TRETINOIN	GEL;TOPICAL	1.2%;0.025%	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68682-300	Clindamycin Phosphate 1.2% and Tretinoin 0.025%	clindamycin phosphate and tretinoin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
99207-300	ZIANA	clindamycin phosphate and tretinoin	Medicis Pharmaceutical Corp	NDA	Current
99207-300	ZIANA	clindamycin phosphate and tretinoin	Bausch Health US, LLC	NDA	Current