FDA NDA · NDA219617

TRABECTEDIN

Sponsor: EVER

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APPLICATION
NDA219617
TYPE
NDA
ORIGINAL APPROVAL
2026-10-01
LATEST ACTION
2026-10-01
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

TRABECTEDIN · ReferencePrescription
TRABECTEDIN 1MG/VIAL · POWDER · INTRAVENOUS

Approval history

2026-10-01Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP