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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210319

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NDA 210319 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 210319

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

Pharmacology for NDA: 210319

Mechanism of Action	NMDA Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 210319

Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Antagonists

Suppliers and Packaging for NDA: 210319

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEMANTINE HYDROCHLORIDE	memantine hydrochloride	SOLUTION;ORAL	210319	ANDA	Seton Pharmaceuticals	13925-540	13925-540-12	360 mL in 1 BOTTLE (13925-540-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	2MG/ML
Approval Date:	Aug 31, 2020	TE:	AA	RLD:	No

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