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AMANTADINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: POM PHARMA · Approved 2021-08-20

Drug application

FDA Application #

ANDA214178

Application type

Abbreviated New Drug Application (Generic)

Brand name

AMANTADINE HYDROCHLORIDE

Generic name

AMANTADINE HYDROCHLORIDE

Active ingredients

AMANTADINE HYDROCHLORIDE

Dosage form

SYRUP

Route

ORAL

Marketing status

Prescription

Sponsor

POM PHARMA

Manufacturer

Patrin Pharma, Inc.

First approval

2021-08-20

Source

Authoritative

Drugs@FDA application overview

Machine

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