Drug application

DICLOFENAC SODIUM (DICLOFENAC SODIUM)

Drugs@FDA ANDA 208068 · PADDOCK LABS

Key facts

Drug name DICLOFENAC SODIUM
Active ingredients DICLOFENAC SODIUM
Application type ANDA
Application number 208068
Company PADDOCK LABS
Dosage forms SOLUTION, TOPICAL
Strength 2%
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Oct 14, 2015

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None 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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