Drug application

APIXABAN (APIXABAN)

Drugs@FDA ANDA 209810 · IMPAX

Key facts

Drug name APIXABAN
Active ingredients APIXABAN
Application type ANDA
Application number 209810
Company IMPAX
Dosage forms TABLET, ORAL
Strength 2.5MG
Marketing status Discontinued
TE codes AB
Reference listed drug No
Latest submission status date Feb 14, 2025

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

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 · Source date:

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