Application 087165

Related Records

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHEGAN	PROMETHAZINE HYDROCHLORIDE	SUPPOSITORY;RECTAL	50MG	No	Yes

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0132	PROMETHEGAN	promethazine hydrochloride	G&W Laboratories, Inc.	ANDA	Current
0713-0132	PROMETHEGAN	promethazine hydrochloride	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0132	PROMETHEGAN	promethazine hydrochloride	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0132	PROMETHEGAN	promethazine hydrochloride	Cosette Pharmaceuticals, Inc.	ANDA	Current
40085-220	Promethazine Hydrochloride	Promethazine Hydrochloride	Renaissance Pharma, Inc.	ANDA	Current
40085-220	Promethazine Hydrochloride	Promethazine Hydrochloride	Renaissance Pharma, Inc.	ANDA	Current

Document	Submission type	Date
43204	ORIG	2011-05-06