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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 212044

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NDA 212044 describes AMANTADINE HYDROCHLORIDE, which is a drug marketed by Zydus, Actavis Elizabeth, Alembic, Bionpharma, Chartwell Molecular, Heritage Pharma, Humanwell Puracap, Invagen Pharms, Onesource Specialty, Rising, Rubicon Research, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Adaptis, Aurobindo Pharma Usa, Chartwell Rx, G And W Labs Inc, Ph Health, Pharm Assoc, Pharmobedient, Shree Hari Intl, Teva Pharms, Athem, Jubilant Generics, and Zhejiang Jutai Pharm, and is included in thirty-six NDAs. It is available from thirty-three suppliers. Additional details are available on the AMANTADINE HYDROCHLORIDE profile page.

The generic ingredient in AMANTADINE HYDROCHLORIDE is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

Summary for 212044

Tradename:	AMANTADINE HYDROCHLORIDE
Applicant:	Rubicon Research
Ingredient:	amantadine hydrochloride
Patents:	0

Pharmacology for NDA: 212044

Mechanism of Action	M2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for 212044

Analgesics, Non-Narcotic
Antiparkinson Agents
Antiviral Agents
Dopamine Agents

Suppliers and Packaging for NDA: 212044

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	CAPSULE;ORAL	212044	ANDA	ST. MARY'S MEDICAL PARK PHARMACY	60760-779	60760-779-30	30 CAPSULE in 1 BOTTLE, PLASTIC (60760-779-30)
AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	CAPSULE;ORAL	212044	ANDA	Bryant Ranch Prepack	71335-2570	71335-2570-1	20 CAPSULE in 1 BOTTLE (71335-2570-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	May 21, 2020	TE:	AB	RLD:	No

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