FDA Approved: MESALAMINE — Original Application (Amneal Pharmaceuticals LLC)

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Summary

FDA approved Amneal's original ANDA for Mesalamine, a generic mesalamine product. This approval authorizes marketing for ulcerative colitis, an inflammatory bow…

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Diseases / indications

• Crohn Disease
• Ulcerative Colitis

Drugs mentioned

• Mesalamine (Mesalamine)

Snippet

ORIG AP for MESALAMINE (MESALAMINE)