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FDA approval · 2025-09-19

FDA Approved: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

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Summary

FDA approved a supplemental application for diphenoxylate hydrochloride and atropine sulfate by ANI Pharmaceuticals, expanding/adjusting the product's labeling …

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Diseases / indications

Drugs mentioned

  • Diphenoxylate hydrochloride and atropine sulfate (Diphenoxylate hydrochloride and atropine sulfate)

Snippet

SUPPL AP for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE)