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AMANTADINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2017-06-21

Drug application

FDA Application #

ANDA208966

Application type

Abbreviated New Drug Application (Generic)

Brand name

AMANTADINE HYDROCHLORIDE

Generic name

AMANTADINE

Active ingredients

AMANTADINE HYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

ALEMBIC

Manufacturer

Alembic Pharmaceuticals Inc.

First approval

2017-06-21

Source

Authoritative

Drugs@FDA application overview

Machine

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