Drug application

DICLOFENAC SODIUM (DICLOFENAC SODIUM)

Drugs@FDA ANDA 075185 · CARLSBAD

Key facts

Drug name DICLOFENAC SODIUM
Active ingredients DICLOFENAC SODIUM
Application type ANDA
Application number 075185
Company CARLSBAD
Dosage forms TABLET, DELAYED RELEASE, ORAL
Strength 75MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Nov 13, 1998

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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