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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207953
Company: JANSSEN PRODS

Medication Guide

Summary Review

Products on NDA 207953

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
YONDELIS	TRABECTEDIN	1MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207953

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/23/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207953s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207953Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207953Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207953Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2020	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207953s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207953Orig1s006ltr.pdf
12/28/2018	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207953Orig1s005ltr.pdf
06/29/2018	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207953Orig1s004ltr.pdf
05/18/2017	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207953s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207953Orig1s003ltr.pdf
07/20/2016	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207953s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207953Orig1s001ltr.pdf

Labels for NDA 207953

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207953s006lbl.pdf
12/28/2018	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s005lbl.pdf
06/29/2018	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s004lbl.pdf
05/18/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207953s003lbl.pdf
07/20/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207953s001lbl.pdf
10/23/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207953s000lbl.pdf

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