You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 19, 2026

Details for New Drug Application (NDA): 214580

✉ Email this page to a colleague

« Back to Dashboard

NDA 214580 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 214580

Tradename:	AMANTADINE HYDROCHLORIDE
Applicant:	Humanwell Puracap
Ingredient:	amantadine hydrochloride
Patents:	0

Pharmacology for NDA: 214580

Mechanism of Action	M2 Protein Inhibitors

Medical Subject Heading (MeSH) Categories for 214580

Analgesics, Non-Narcotic
Antiparkinson Agents
Antiviral Agents
Dopamine Agents

Suppliers and Packaging for NDA: 214580

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	CAPSULE;ORAL	214580	ANDA	EPIC PHARMA LLC	42806-716	42806-716-05	500 CAPSULE in 1 BOTTLE (42806-716-05)
AMANTADINE HYDROCHLORIDE	amantadine hydrochloride	CAPSULE;ORAL	214580	ANDA	EPIC PHARMA LLC	42806-716	42806-716-11	10 CAPSULE in 1 BOTTLE (42806-716-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Dec 20, 2022	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.