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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 090058

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NDA 090058 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 090058

Tradename:	MEMANTINE HYDROCHLORIDE
Applicant:	Sun Pharm
Ingredient:	memantine hydrochloride
Patents:	0

Pharmacology for NDA: 090058

Mechanism of Action	NMDA Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 090058

Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Antagonists

Suppliers and Packaging for NDA: 090058

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	090058	ANDA	Sun Pharmaceutical Industries, Inc.	47335-321	47335-321-08	100 TABLET, FILM COATED in 1 BOTTLE (47335-321-08)
MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	090058	ANDA	Sun Pharmaceutical Industries, Inc.	47335-321	47335-321-18	1000 TABLET, FILM COATED in 1 BOTTLE (47335-321-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 5, 2010	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 5, 2010	TE:	AB	RLD:	No

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