Drug application

DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM, MISOPROSTOL)

Drugs@FDA ANDA 200540 · EXELA HOLDINGS

Key facts

Drug name DICLOFENAC SODIUM AND MISOPROSTOL
Active ingredients DICLOFENAC SODIUM, MISOPROSTOL
Application type ANDA
Application number 200540
Company EXELA HOLDINGS
Dosage forms TABLET, DELAYED RELEASE, ORAL
Strength 50MG;0.2MG
Marketing status Discontinued
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Mar 14, 2014

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents

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

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