Drug application

DICLOFENAC SODIUM (DICLOFENAC SODIUM)

Drugs@FDA ANDA 075492 · VPNA

Key facts

Drug name DICLOFENAC SODIUM
Active ingredients DICLOFENAC SODIUM
Application type ANDA
Application number 075492
Company VPNA
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 100MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Feb 11, 2000

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • Yes 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:

Browse all Drugs@FDA applications