Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsORALGeneric

DICLOFENAC SODIUM AND MISOPROSTOL

DICLOFENAC SODIUM; MISOPROSTOL

Standard Dose
75MG;0.2MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview DICLOFENAC SODIUM AND MISOPROSTOL is listed in Drugs@FDA under application 206771 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient DICLOFENAC SODIUM; MISOPROSTOL Form and strength TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2023-06-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview DICLOFENAC SODIUM AND MISOPROSTOL is listed in Drugs@FDA under application 206771 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient DICLOFENAC SODIUM; MISOPROSTOL Form and strength TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2023-06-12 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.