Drug application

BICALUTAMIDE (BICALUTAMIDE)

Drugs@FDA ANDA 076932 · TEVA

Key facts

Drug name BICALUTAMIDE
Active ingredients BICALUTAMIDE
Application type ANDA
Application number 076932
Company TEVA
Dosage forms TABLET, ORAL
Strength 50MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Jul 6, 2009

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None 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:

Browse all Drugs@FDA applications