Details for New Drug Application (NDA): 207953

NDA 207953 describes YONDELIS, which is a drug marketed by Janssen Prods and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the YONDELIS profile page.

The generic ingredient in YONDELIS is trabectedin. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trabectedin profile page.

Summary for 207953

Tradename:	YONDELIS
Applicant:	Janssen Prods
Ingredient:	trabectedin
Patents:	1

Pharmacology for NDA: 207953

Mechanism of Action

Alkylating Activity

Suppliers and Packaging for NDA: 207953

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
YONDELIS	trabectedin	POWDER;INTRAVENOUS	207953	NDA	Janssen Products, LP	59676-610	59676-610-01	20 mL in 1 VIAL, SINGLE-USE (59676-610-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	1MG/VIAL
Approval Date:	Oct 23, 2015	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 23, 2022
Regulatory Exclusivity Use:	FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA OR LEIOMYOSARCOMA WHO RECEIVED A PRIOR ANTHRACYCLINE-CONTAINING REGIMEN
Regulatory Exclusivity Expiration:	Apr 23, 2023
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:		Patent Expiration:	Jul 7, 2028	Product Flag?		Substance Flag?		Delist Request?	Y

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