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AMANTADINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BIONPHARMA · Approved 2008-05-29

Drug application

FDA Application #

ANDA078720

Application type

Abbreviated New Drug Application (Generic)

Brand name

AMANTADINE HYDROCHLORIDE

Generic name

AMANTADINE HYDROCHLORIDE

Active ingredients

AMANTADINE HYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

BIONPHARMA

Manufacturer

Bionpharma Inc.

First approval

2008-05-29

Source

Authoritative

Drugs@FDA application overview

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