Drug application

PONATINIB (PONATINIB)

Drugs@FDA ANDA 217825 · TEVA PHARMS INC

Key facts

Drug name PONATINIB
Active ingredients PONATINIB
Application type ANDA
Application number 217825
Company TEVA PHARMS INC
Dosage forms TABLET, ORAL
Strength 10MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Oct 26, 2023

At a glance

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

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