cangrelor Injection

Brand(s)
Kengreal
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
The Medicines Company (2015-07-09)
Oldest Current Product
2015-07-08
License(s)
NDA
RxNORM
INJECTION\CANGRELOR
FDAOB
IV (INFUSION)\POWDER\CANGRELOR\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CANGRELOR
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CANGRELOR

product(s) by strength(s)

cangrelor 50 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1652930003KengrealNDAThe Medicines Company2015-07-08CANGRELORINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA204958fd5534d0-92c8-41bf-9eca-8259405fbfc2

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204958KENGREALTHE MEDICINES CO2015-06-22p6114313, P2Y12 PLATELET INHIBITOR FOR USE AS ADJUNCT TO PERCUTANEOUS CORONARY INTERVENTIONTO REDUCE RISK OF VARIOUS DISEASES/CONDITIONS IN PATIENTS NOT TREATED WITH A P2Y12 PLATELET INHIBITOR AND NOT GIVEN A GLYCOPROTEIN IIB/IIIA INHIBITOR, SUBSTANCE
p6130208, P2Y12 PLATELET INHIBITOR FOR USE AS ADJUNCT TO PERCUTANEOUS CORONARY INTERVENTIONTO REDUCE RISK OF VARIOUS DISEASES/CONDITIONS IN PATIENTS NOT TREATED WITH A P2Y12 PLATELET INHIBITOR AND NOT GIVEN A GLYCOPROTEIN IIB/IIIA INHIBITOR, SUBSTANCE
p8680052, P2Y12 PLATELET INHIBITOR FOR USE AS ADJUNCT TO PERCUTANEOUS CORONARY INTERVENTIONTO REDUCE RISK OF VARIOUS DISEASES/CONDITIONS IN PATIENTS NOT TREATED WITH A P2Y12 PLATELET INHIBITOR AND NOT GIVEN A GLYCOPROTEIN IIB/IIIA INHIBITOR
p8759316, P2Y12 PLATELET INHIBITOR FOR USE AS ADJUNCT TO PERCUTANEOUS CORONARY INTERVENTIONTO REDUCE RISK OF VARIOUS DISEASES/CONDITIONS IN PATIENTS NOT TREATED WITH A P2Y12 PLATELET INHIBITOR AND NOT GIVEN A GLYCOPROTEIN IIB/IIIA INHIBITOR
NEW CHEMICAL ENTITY [2020-06-22]NDA204958_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA204958_001RXCANGRELOR (50MG/VIAL)POWDERTrue2015-06-22KENGREAL

patent(s)

#idexpiration dateapplication(s)
1p6114313 (view patent)2017-12-11NDA204958
2p6130208 (view patent)2018-06-29NDA204958
3p8680052 (view patent)2033-03-09NDA204958
4p8759316 (view patent)2029-05-13NDA204958

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1fd5534d0-92c8-41bf-9eca-8259405fbfc2 (view SPL)These highlights do not include all the information needed to use KENGREAL safely and effectively. See full prescribing information for KENGREAL. KENGREAL ( c angrelor) for injection, for intravenous use Initial U.S. Approval: 201 5prescriptionHuman PrescriptionThe Medicines Company2015-07-092652930003

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