Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2007-10-22

FDA Approved: AMIODARONE HYDROCHLORIDE — Supplemental Application (Fresenius Kabi USA, LLC)

View source ↗

Summary

FDA approved a supplemental application for amiodarone hydrochloride (ANDA 075761) to support its manufacture by Fresenius Kabi USA, LLC.

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

Diseases / indications

Drugs mentioned

  • AMIODARONE HYDROCHLORIDE (Amiodarone hydrochloride)

Snippet

SUPPL AP for AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)