Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2017-05-23

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

View source ↗

Summary

FDA approved a supplemental application for a generic Buprenorphine and Naloxone product from PAI Holdings under ANDA 204431.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

Drugs mentioned

  • Buprenorphine and naloxone (BUPRENORPHINE AND NALOXONE)

Snippet

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