Details for New Drug Application (NDA): 212407

NDA 212407 describes AMANTADINE HYDROCHLORIDE, which is a drug marketed by Zydus, Actavis Elizabeth, Alembic, Bionpharma, Chartwell Molecular, Heritage Pharma, Humanwell Puracap, Invagen Pharms, Rising, Rubicon, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Aurobindo Pharma Usa, Chartwell Rx, Cmp Pharma Inc, Elysium, Endo Operations, G And W Labs Inc, Pharm Assoc, Teva Pharms, Xttrium Labs Inc, Adaptis, Athem, Jubilant Generics, and Zhejiang Jutai Pharm, and is included in thirty-six NDAs. It is available from thirty-two 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-three suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

Summary for 212407

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

Pharmacology for NDA: 212407

Mechanism of Action

M2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for 212407

Analgesics, Non-Narcotic

Antiparkinson Agents

Antiviral Agents

Dopamine Agents

Suppliers and Packaging for NDA: 212407

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	TABLET;ORAL	212407	ANDA	Edenbridge Pharmaceuticals LLC.	42799-118	42799-118-01	100 TABLET in 1 BOTTLE (42799-118-01)
AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	TABLET;ORAL	212407	ANDA	Edenbridge Pharmaceuticals LLC.	42799-118	42799-118-02	500 TABLET in 1 BOTTLE (42799-118-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	May 27, 2022	TE:		RLD:	No

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