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ARIPIPRAZOLE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BARR LABS INC · Approved 2012-11-29

Drug application

FDA Application #

ANDA078612

Application type

Abbreviated New Drug Application (Generic)

Brand name

ARIPIPRAZOLE

Generic name

Aripiprazole

Active ingredients

ARIPIPRAZOLE

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

BARR LABS INC

First approval

2012-11-29

Source

Authoritative

Drugs@FDA application overview

Machine

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