Last Updated: May 11, 2026

Details for New Drug Application (NDA): 090041

✉ Email this page to a colleague

« Back to Dashboard

NDA 090041 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, 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 090041

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

Pharmacology for NDA: 090041

Mechanism of Action	NMDA Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 090041

Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Antagonists

Suppliers and Packaging for NDA: 090041

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	090041	ANDA	Amneal Pharmaceuticals of New York LLC	53746-169	53746-169-10	1000 TABLET, FILM COATED in 1 BOTTLE (53746-169-10)
MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	090041	ANDA	Amneal Pharmaceuticals of New York LLC	53746-169	53746-169-30	30 TABLET, FILM COATED in 1 BOTTLE (53746-169-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 10, 2015	TE:	AB	RLD:	No

Profile for product number 002

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.