General MedicationsINTRAVENOUSStandard
YONDELIS
TRABECTEDIN
Standard Dose
1MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview YONDELIS is listed in Drugs@FDA under application 207953 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TRABECTEDIN Form and strength POWDER;INTRAVENOUS - 1MG/VIAL Sponsor JANSSEN PRODS Submission history Latest submission status date: 2025-12-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview YONDELIS is listed in Drugs@FDA under application 207953 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TRABECTEDIN Form and strength POWDER;INTRAVENOUS - 1MG/VIAL Sponsor JANSSEN PRODS Submission history Latest submission status date: 2025-12-23 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.