Drug application

DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM, MISOPROSTOL)

Drugs@FDA ANDA 205143 · YUNG SHIN PHARM

Key facts

Drug name DICLOFENAC SODIUM AND MISOPROSTOL
Active ingredients DICLOFENAC SODIUM, MISOPROSTOL
Application type ANDA
Application number 205143
Company YUNG SHIN PHARM
Dosage forms TABLET, DELAYED RELEASE, ORAL
Strength 50MG;0.2MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Feb 19, 2020

At a glance

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