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FDA ANDA · ANDA078613

ARIPIPRAZOLE

Sponsor: BARR LABS INC

APPLICATION
ANDA078613
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

ARIPIPRAZOLENone (Tentative Approval)
ARIPIPRAZOLE 20MG · TABLET · ORAL
ARIPIPRAZOLENone (Tentative Approval)
ARIPIPRAZOLE 10MG · TABLET · ORAL
ARIPIPRAZOLENone (Tentative Approval)
ARIPIPRAZOLE 2MG · TABLET · ORAL
ARIPIPRAZOLENone (Tentative Approval)
ARIPIPRAZOLE 30MG · TABLET · ORAL
ARIPIPRAZOLENone (Tentative Approval)
ARIPIPRAZOLE 15MG · TABLET · ORAL
ARIPIPRAZOLENone (Tentative Approval)
ARIPIPRAZOLE 5MG · TABLET · ORAL

Approval history

2012-10-12OriginalTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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