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AMANTADINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA USA · Approved 1994-10-28

Drug application

FDA Application #

ANDA074170

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

AUROBINDO PHARMA USA

First approval

1994-10-28

Source

Authoritative

Drugs@FDA application overview

Machine

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