Application 205905

Type: ANDA
Sponsor: SUN PHARM

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
16714-959	memantine hydrochloride	memantine hydrochloride	NorthStar RxLLC	ANDA	Current
16714-959	memantine hydrochloride	memantine hydrochloride	NorthStar RxLLC	ANDA	Current
16714-960	memantine hydrochloride	memantine hydrochloride	NorthStar RxLLC	ANDA	Current
16714-960	memantine hydrochloride	memantine hydrochloride	NorthStar RxLLC	ANDA	Current
16714-961	memantine hydrochloride	memantine hydrochloride	NorthStar RxLLC	ANDA	Current
16714-961	memantine hydrochloride	memantine hydrochloride	NorthStar RxLLC	ANDA	Current
16714-962	memantine hydrochloride	memantine hydrochloride	NorthStar RxLLC	ANDA	Current
16714-962	memantine hydrochloride	memantine hydrochloride	NorthStar RxLLC	ANDA	Current
47335-031	memantine hydrochloride	memantine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-031	memantine hydrochloride	memantine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-032	memantine hydrochloride	memantine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-032	memantine hydrochloride	memantine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-033	memantine hydrochloride	memantine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-033	memantine hydrochloride	memantine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-034	memantine hydrochloride	memantine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-034	memantine hydrochloride	memantine hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45604	ORIG	2016-10-11
45442	ORIG	2016-10-03