General MedicationsINJECTIONStandard
NEXTERONE
AMIODARONE HYDROCHLORIDE
Standard Dose
360MG/200ML (1.8MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview NEXTERONE is listed in Drugs@FDA under application 022325 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient AMIODARONE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - 360MG/200ML (1.8MG/ML) Sponsor BAXTER HLTHCARE Submission history Latest submission status date: 2025-02-21 00:00:00.
Structured Monograph
Clinical summary
Approval overview NEXTERONE is listed in Drugs@FDA under application 022325 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMIODARONE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - 360MG/200ML (1.8MG/ML) Sponsor BAXTER HLTHCARE Submission history Latest submission status date: 2025-02-21 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.