Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2025-11-10

FDA Approved: DALBAVANCIN HYDROCHLORIDE — Original Application (Fresenius Kabi USA, LLC)

View source ↗

Summary

FDA approved the original application for dalbavancin hydrochloride (Fresenius Kabi USA, LLC), authorizing its generic formulation for use in bacterial skin and…

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

Diseases / indications

Drugs mentioned

  • DALBAVANCIN HYDROCHLORIDE (dalbavancin hydrochloride)

Snippet

ORIG AP for DALBAVANCIN HYDROCHLORIDE (DALBAVANCIN HYDROCHLORIDE)