Drug application

PONATINIB HYDROCHLORIDE (PONATINIB HYDROCHLORIDE)

Drugs@FDA ANDA 215893 · APOTEX

Key facts

Drug name PONATINIB HYDROCHLORIDE
Active ingredients PONATINIB HYDROCHLORIDE
Application type ANDA
Application number 215893
Company APOTEX
Dosage forms TABLET, ORAL
Strength EQ 15MG BASE
Marketing status Discontinued
TE codes AB
Reference listed drug No
Latest submission status date Jul 14, 2023

At a glance

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