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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205365

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NDA 205365 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Ph Health, Rising, Sun Pharm, Vitruvias, Yichang Humanwell, Zydus Pharms, Chartwell Molecular, Sciegen Pharms Inc, Seton Pharms, Ajanta Pharma Ltd, Alembic, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Orbion Pharms, Pointview Hldings, Polygen Pharms, Puracap Pharm Llc, Somerset Theraps Llc, Strides Pharma, Teva Pharms, Torrent, Unichem, Upsher Smith Labs, Yiling, Zydus Lifesciences, Amneal, and Xiamen Lp Pharm Co, and is included in forty-seven NDAs. It is available from thirty-nine suppliers. Additional details are available on the MEMANTINE HYDROCHLORIDE profile page.

The generic ingredient in MEMANTINE HYDROCHLORIDE is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.

Summary for 205365

Tradename:	MEMANTINE HYDROCHLORIDE
Applicant:	Ani Pharms
Ingredient:	memantine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 205365

Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	7MG
Approval Date:	Feb 28, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	14MG
Approval Date:	Feb 28, 2020	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	21MG
Approval Date:	Feb 28, 2020	TE:		RLD:	No

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