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Details for New Drug Application (NDA): 207953

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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 NDA: 207953


Pharmacology for NDA: 207953

Mechanism of ActionAlkylating Activity

Suppliers and Packaging for NDA: 207953

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)Strength1MG/VIAL
Approval Date:Oct 23, 2015TE:RLD:Yes
Patent:8,895,557Patent Expiration:Jan 7, 2028Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Oct 23, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 23, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.