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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 070589

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NDA 070589 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 070589

Tradename:	AMANTADINE HYDROCHLORIDE
Applicant:	Upsher Smith Labs
Ingredient:	amantadine hydrochloride
Patents:	0

Pharmacology for NDA: 070589

Mechanism of Action	M2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for 070589

Analgesics, Non-Narcotic
Antiparkinson Agents
Antiviral Agents
Dopamine Agents

Suppliers and Packaging for NDA: 070589

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	CAPSULE;ORAL	070589	ANDA	Upsher-Smith Laboratories, LLC	0832-1015	0832-1015-00	100 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-00)
AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	CAPSULE;ORAL	070589	ANDA	Upsher-Smith Laboratories, LLC	0832-1015	0832-1015-50	500 CAPSULE, GELATIN COATED in 1 BOTTLE (0832-1015-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Aug 5, 1986	TE:	AB	RLD:	No

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