Last Updated: June 25, 2026

Details for New Drug Application (NDA): 202840

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NDA 202840 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Lupin, Macleods Pharms Ltd, Ph Health, Rising, Sun Pharm, Vitruvias, Yichang Humanwell, Zydus Pharms, Chartwell Molecular, Medley Pharms, Sciegen Pharms, Ajanta Pharma Ltd, Alembic, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Orbion Pharms, Pointview Hldings, Puracap Labs Blu, Puracap Pharm Llc, Renata, 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 202840

Tradename:	MEMANTINE HYDROCHLORIDE
Applicant:	Macleods Pharms Ltd
Ingredient:	memantine hydrochloride
Patents:	0

Pharmacology for NDA: 202840

Mechanism of Action	NMDA Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 202840

Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Antagonists

Suppliers and Packaging for NDA: 202840

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	202840	ANDA	Macleods Pharmaceuticals Limited	33342-297	33342-297-09	60 TABLET in 1 BOTTLE (33342-297-09)
MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	202840	ANDA	Macleods Pharmaceuticals Limited	33342-297	33342-297-12	10 BLISTER PACK in 1 CARTON (33342-297-12) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Oct 13, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 13, 2015	TE:	AB	RLD:	No

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