vincristine liposome Injectable Suspension

Brand(s)
Marqibo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Talon Therapeutics, Inc (2012-10-03)
Oldest Current Product
2013-01-14
License(s)
NDA
RxNORM
INJECTABLE SUSPENSION\VINCRISTINE LIPOSOME
FDAOB
INTRAVENOUS\INJECTABLE, LIPOSOMAL\VINCRISTINE SULFATE

product(s) by strength(s)

vincristine sulfate liposome 0.16 mg/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1205360322MarqiboNDATalon Therapeutics, Inc2013-01-14NDA202497a1869e23-b93b-4407-843b-4b830319d82e

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202497MARQIBO KITTALON THERAPEUTICS INC2012-08-09p7887836, TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-NEGATIVE(PH-) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN SECOND OR GREATER RELAPSE OR WHOSE DISEASE HAS PROGRESSED FOLLOWING TWO OR MOR ANTI-LEUKEMIA THERAPIES
p6723338, TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-NEGATIVE(PH-) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN SECOND OR GREATER RELAPSE OR WHOSE DISEASE HAS PROGRESSED FOLLOWING TWO OR MOR ANTI-LEUKEMIA THERAPIES
p7247316, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2019-08-09]
NEW PRODUCT [2015-08-09]
NDA202497_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202497_001RXVINCRISTINE SULFATE (5MG/5ML)INTRAVENOUSINJECTABLE, LIPOSOMALTrue2012-08-09MARQIBO KIT

patent(s)

#idexpiration dateapplication(s)
1p6723338 (view patent)2020-03-31NDA202497
2p7247316 (view patent)2020-09-25NDA202497
3p7887836 (view patent)2020-03-31NDA202497

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a1869e23-b93b-4407-843b-4b830319d82e (view SPL)These highlights do not include all the information needed to use Marqibo (vinCRIStine sulfate LIPOSOME injection) safely and effectively. See Full Prescribing Information for Marqibo (vinCRIStine sulfate LIPOSOME injection). Marqibo (vinCRIStine sulfate LIPOSOME injection) for intravenous infusionInitial U.S. Approval: 2012prescriptionHuman PrescriptionTalon Therapeutics, IncANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2012-10-034205360322

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII