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FDA approval · 2019-10-09

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

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Summary

FDA approved a supplemental application for buprenorphine hydrochloride, indicating regulatory clearance for the generic product from PAI Holdings/PAI Pharma.

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Diseases / indications

Drugs mentioned

  • Buprenorphine Hydrochloride (Buprenorphine hydrochloride)

Snippet

SUPPL AP for BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)