Drug application

ABIRATERONE ACETATE (ABIRATERONE ACETATE)

Drugs@FDA ANDA 208432 · TEVA PHARMS USA

Key facts

Drug name ABIRATERONE ACETATE
Active ingredients ABIRATERONE ACETATE
Application type ANDA
Application number 208432
Company TEVA PHARMS USA
Dosage forms TABLET, ORAL
Strength 250MG
Marketing status Discontinued
TE codes AB
Reference listed drug No
Latest submission status date Oct 31, 2018

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 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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