Application 203293

Type: ANDA
Sponsor: ZYDUS 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
68382-546	Memantine hydrochloride	Memantine hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-546	Memantine hydrochloride	Memantine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-546	Memantine hydrochloride	Memantine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-547	Memantine hydrochloride	Memantine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-547	Memantine hydrochloride	Memantine hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-547	Memantine hydrochloride	Memantine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-548	Memantine hydrochloride	Memantine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-548	Memantine hydrochloride	Memantine hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-548	Memantine hydrochloride	Memantine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-549	Memantine hydrochloride	Memantine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-549	Memantine hydrochloride	Memantine hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-549	Memantine hydrochloride	Memantine hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1321	Memantine hydrochloride	Memantine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1321	Memantine hydrochloride	Memantine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1321	Memantine hydrochloride	Memantine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1321	Memantine hydrochloride	Memantine hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1322	Memantine hydrochloride	Memantine hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1322	Memantine hydrochloride	Memantine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1322	Memantine hydrochloride	Memantine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1322	Memantine hydrochloride	Memantine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1323	Memantine hydrochloride	Memantine hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1323	Memantine hydrochloride	Memantine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1323	Memantine hydrochloride	Memantine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1323	Memantine hydrochloride	Memantine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1324	Memantine hydrochloride	Memantine hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1324	Memantine hydrochloride	Memantine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1324	Memantine hydrochloride	Memantine hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1324	Memantine hydrochloride	Memantine hydrochloride	Cadila Healthcare Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49277	ORIG	2017-08-08

Application 203293

Related Records#

Application Products#

NDC Listings For This Application#

Documents#