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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 214651

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NDA 214651 describes MEMANTINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Endo Operations, Lupin Ltd, Rising, Sun Pharm, Xiamen Lp Pharm Co, Yichang Humanwell, Zydus Pharms, Chartwell Molecular, Macleods Pharms Ltd, Sciegen Pharms Inc, Seton Pharms, Acme Labs, Ajanta Pharma Ltd, Alembic, Allied, Chartwell, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Orbion Pharms, Polygen Pharms, Puracap Pharm Llc, Strides Pharma, Teva Pharms, Torrent, Unichem, Upsher Smith Labs, Yiling, and Zydus Lifesciences, and is included in forty-four 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. Two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.

Summary for 214651

Tradename:	MEMANTINE HYDROCHLORIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	memantine hydrochloride
Patents:	0

Pharmacology for NDA: 214651

Mechanism of Action	NMDA Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 214651

Antiparkinson Agents
Dopamine Agents
Excitatory Amino Acid Antagonists

Suppliers and Packaging for NDA: 214651

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEMANTINE HYDROCHLORIDE	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	214651	ANDA	Aurobindo Pharma Limited	59651-404	59651-404-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-404-30)
MEMANTINE HYDROCHLORIDE	memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	214651	ANDA	Aurobindo Pharma Limited	59651-404	59651-404-90	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-404-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	7MG
Approval Date:	Aug 9, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	14MG
Approval Date:	Aug 9, 2021	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	21MG
Approval Date:	Aug 9, 2021	TE:	AB	RLD:	No

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