Diclofenac Sodium and Misoprostol

Amneal Pharmaceuticals LLC🇺🇸 United States

FDA Page

Effective Date: Mar 10, 2023
Approval ID: afd30051-8f59-474b-9972-962a5a871dfb
Products: 2 registered
Version: 24

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS. DICLOFENAC SODIUM and MISOPROSTOL delayed-release tablets, for oral use Initial U.S. Approval: 1997

Quick Stats

Total Products2

Labelers2

Label Sections18

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.