Drug application

IRBESARTAN (IRBESARTAN)

Drugs@FDA ANDA 200832 · APOTEX INC

Key facts

Drug name IRBESARTAN
Active ingredients IRBESARTAN
Application type ANDA
Application number 200832
Company APOTEX INC
Dosage forms TABLET, ORAL
Strength 75MG
Marketing status Discontinued
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Oct 15, 2012

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 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

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