Application 216446

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	SUPPOSITORY;RECTAL	12.5MG	No	No
002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	SUPPOSITORY;RECTAL	25MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-040	Promethazine Hydrochloride	Promethazine Hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-041	Promethazine Hydrochloride	Promethazine Hydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current