Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2015-02-04

FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

View source ↗

Summary

FDA approved a supplemental application for Hikma's buprenorphine hydrochloride and naloxone hydrochloride dihydrate product for opioid use disorder.

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

Diseases / indications

Drugs mentioned

  • Buprenorphine hydrochloride and naloxone hydrochloride dihydrate (buprenorphine hydrochloride and naloxone hydrochloride dihydrate)

Snippet

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