Drug application

DIFLUNISAL (DIFLUNISAL)

Drugs@FDA ANDA 203547 · ZYDUS PHARMS

Key facts

Drug name DIFLUNISAL
Active ingredients DIFLUNISAL
Application type ANDA
Application number 203547
Company ZYDUS PHARMS
Dosage forms TABLET, ORAL
Strength 500MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jun 16, 2017

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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