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FDA approval · 2019-10-09

FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)

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Summary

The FDA approved a supplemental application for a generic buprenorphine and naloxone product from PAI Holdings/PAI Pharma, authorizing the ANDA supplement and a…

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Diseases / indications

Drugs mentioned

  • Buprenorphine and naloxone (BUPRENORPHINE AND NALOXONE)

Snippet

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