Last Updated: September 24, 2026

Details for New Drug Application (NDA): 204389

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NDA 204389 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Lupin, Macleods Pharms, Ph Health, Rising, Sun Pharm, Vitruvias, Yichang Humanwell, Zydus Pharms, Apozeal Pharms, Chartwell Molecular, Medley Pharms, Ajanta Pharma Ltd, Alembic, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, 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-eight suppliers. Additional details are available on the MEMANTINE HYDROCHLORIDE profile page.

The generic ingredient in MEMANTINE HYDROCHLORIDE is donepezil hydrochloride; memantine hydrochloride. There are 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 204389

Tradename:	MEMANTINE HYDROCHLORIDE
Applicant:	Hetero Labs Ltd V
Ingredient:	memantine hydrochloride
Patents:	0

Pharmacology for NDA: 204389

Mechanism of Action	NMDA Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 204389

Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Antagonists

Suppliers and Packaging for NDA: 204389

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	204389	ANDA	Camber Pharmaceuticals, Inc.	31722-807	31722-807-02	200 TABLET in 1 BOTTLE (31722-807-02)
MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	204389	ANDA	Camber Pharmaceuticals, Inc.	31722-807	31722-807-32	10 BLISTER PACK in 1 CARTON (31722-807-32) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Sep 26, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 26, 2022	TE:	AB	RLD:	No

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