Application 205825

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	7MG	No	No
002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	14MG	No	No
003	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	21MG	No	No
004	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	28MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-782	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-782	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-782	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-782	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-783	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-783	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-783	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-783	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-784	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-784	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-784	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-784	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-785	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-785	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-785	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-785	Memantine Hydrochloride	Memantine Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current