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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 075819

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NDA 075819 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 075819

Tradename:	AMANTADINE HYDROCHLORIDE
Applicant:	Adaptis
Ingredient:	amantadine hydrochloride
Patents:	0

Pharmacology for NDA: 075819

Mechanism of Action	M2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for 075819

Analgesics, Non-Narcotic
Antiparkinson Agents
Antiviral Agents
Dopamine Agents

Suppliers and Packaging for NDA: 075819

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	SYRUP;ORAL	075819	ANDA	BAJAJ MEDICAL, LLC	61037-484	61037-484-03	473 mL in 1 BOTTLE (61037-484-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	50MG/5ML
Approval Date:	Sep 11, 2002	TE:		RLD:	No

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