General MedicationsINTRAVENOUSStandard
ZEPZELCA
LURBINECTEDIN
Standard Dose
4MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ZEPZELCA is listed in Drugs@FDA under application 213702 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LURBINECTEDIN Form and strength POWDER;INTRAVENOUS - 4MG/VIAL Sponsor JAZZ Submission history Latest submission status date: 2026-02-27 00:00:00.
Structured Monograph
Clinical summary
Approval overview ZEPZELCA is listed in Drugs@FDA under application 213702 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LURBINECTEDIN Form and strength POWDER;INTRAVENOUS - 4MG/VIAL Sponsor JAZZ Submission history Latest submission status date: 2026-02-27 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.