Drug application

ARIPIPRAZOLE (ARIPIPRAZOLE)

Drugs@FDA ANDA 078612 · BARR LABS INC

Key facts

Drug name ARIPIPRAZOLE
Active ingredients ARIPIPRAZOLE
Application type ANDA
Application number 078612
Company BARR LABS INC
Dosage forms TABLET, ORALLY DISINTEGRATING, ORAL
Strength 10MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Nov 29, 2012

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

Browse all Drugs@FDA applications