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FDA approval · 2025-12-22

FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)

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Summary

FDA approved Amneal's supplemental application for a generic Buprenorphine HCl and Naloxone HCl product for the treatment of opioid use disorder.

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Diseases / indications

Drugs mentioned

  • Buprenorphine HCl and Naloxone HCl (Buprenorphine and Naloxone)

Snippet

SUPPL AP for BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE)