FDA Approved: URSODIOL — Original Application (Amneal Pharmaceuticals NY LLC)

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Summary

FDA approved Amneal's Ursodiol generic under an Original Application (ANDA 211301), enabling its marketing as a generic therapy.

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Diseases / indications

• Biliary Cholangitis
• Gallstone Disease

Drugs mentioned

• URSODIOL (ursodiol)

Snippet

ORIG AP for URSODIOL (URSODIOL)