Drug application

CAPECITABINE (CAPECITABINE)

Drugs@FDA ANDA 091649 · TEVA PHARMS USA

Key facts

Drug name CAPECITABINE
Active ingredients CAPECITABINE
Application type ANDA
Application number 091649
Company TEVA PHARMS USA
Dosage forms TABLET, ORAL
Strength 150MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Sep 16, 2013

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 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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