Details for New Drug Application (NDA): 209035

NDA 209035 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 209035

Tradename:	AMANTADINE HYDROCHLORIDE
Applicant:	Strides Pharma
Ingredient:	amantadine hydrochloride
Patents:	0

Pharmacology for NDA: 209035

Mechanism of Action

M2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for 209035

Analgesics, Non-Narcotic

Antiparkinson Agents

Antiviral Agents

Dopamine Agents

Suppliers and Packaging for NDA: 209035

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	TABLET;ORAL	209035	ANDA	Strides Pharma Inc.	42543-497	42543-497-01	100 TABLET in 1 BOTTLE (42543-497-01)
AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	TABLET;ORAL	209035	ANDA	Strides Pharma Inc.	42543-497	42543-497-05	500 TABLET in 1 BOTTLE (42543-497-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jun 9, 2017	TE:	AB	RLD:	No

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