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FDA NDA · NDA207953

YONDELIS

trabectedin

Sponsor: JANSSEN PRODS

APPLICATION
NDA207953
TYPE
NDA
ORIGINAL APPROVAL
2015-10-23
LATEST ACTION
2025-12-23
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

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

Approval history

2025-12-23Labeling · Supplement 9 · standard — Letter ↗AP
2020-06-03Labeling · Supplement 6 · standard — Label ↗AP
2018-12-28Labeling · Supplement 5 · standard — Letter ↗AP
2018-06-29Efficacy · Supplement 4 · priority — Label ↗AP
2017-05-18Labeling · Supplement 3 · standard — Label ↗AP
2016-07-20Labeling · Supplement 1 · standard — Label ↗AP
2015-10-23Type 1 - New Molecular Entity · Original · priority — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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