Drug application

IMATINIB MESYLATE (IMATINIB MESYLATE)

Drugs@FDA ANDA 078340 · SUN PHARM

Key facts

Drug name IMATINIB MESYLATE
Active ingredients IMATINIB MESYLATE
Application type ANDA
Application number 078340
Company SUN PHARM
Dosage forms TABLET, ORAL
Strength EQ 100MG BASE
Marketing status Discontinued
TE codes AB
Reference listed drug No
Latest submission status date Dec 3, 2015

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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