bivalirudin Injection

Brand(s)
Angiomax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2015-10-21)
Oldest Current Product
2000-12-15
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
INJECTION\BIVALIRUDIN
FDAOB
INTRAVENOUS\INJECTION\BIVALIRUDIN
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BIVALIRUDIN
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BIVALIRUDIN

product(s) by strength(s)

bivalirudin 250 mg injection

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1007813158Sandoz IncBIVALIRUDININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONce56f806-7845-429d-a1ce-c2dbf79b22eb

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004098300ANDAHospira, Inc.2015-07-14BIVALIRUDININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA090811, ANDA0908167f3b2717-056e-4edb-a9b0-a63efa008d2b, 9f8f693d-e3bd-449f-0db2-4bb77d6c993c
2007819158NDA AUTHORIZED GENERICSandoz Inc2015-10-23BIVALIRUDININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA0208732990d917-666b-4b84-8f54-605a299e3790

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551542275AngiomaxNDACardinal Health2000-12-15BIVALIRUDININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION652930001NDA020873799d3b00-809b-4abc-989c-05faccec49f8

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA090811BIVALIRUDINHOSPIRA INC2015-07-14ANDA090811_001
2ANDA090816BIVALIRUDINHOSPIRA INC2015-07-14ANDA090816_001
3NDA020873ANGIOMAXTHE MEDICINES CO2000-12-15p7582727, SUBSTANCE
p7598343, SUBSTANCE
p5196404, USE AS ANTICOAGULANT IN PTS W/ UNSTABLE ANGINA UNDERGOING PTCA; W/ PROVISIONAL USE OF GLYCOPROTEIN IIB/IIIA INHIBITOR/ INHIBITION OF THROMBIN IN A PATIENT, SUBSTANCE
NDA020873_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA090811_001RXBIVALIRUDIN (250MG/VIAL)INTRAVENOUSINJECTIONFalseAP2015-07-14BIVALIRUDIN
2ANDA090816_001RXBIVALIRUDIN (250MG/VIAL)INTRAVENOUSINJECTIONFalseAP2015-07-14BIVALIRUDIN
3NDA020873_001RXBIVALIRUDIN (250MG/VIAL)INTRAVENOUSINJECTIONTrueAP2000-12-15ANGIOMAX

patent(s)

#idexpiration dateapplication(s)
1p5196404 (view patent)2014-12-15NDA020873
2p7582727 (view patent)2028-07-27NDA020873
3p7598343 (view patent)2028-07-27NDA020873

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12990d917-666b-4b84-8f54-605a299e3790 (view SPL)These highlights do not include all the information needed to use Bivalirudin safely and effectively. See full prescribing information for Bivalirudin. Bivalirudin for injection, for intravenous use Initial U.S. Approval: 2000prescriptionHuman PrescriptionSandoz IncANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-10-211007819158
2799d3b00-809b-4abc-989c-05faccec49f8 (view SPL)These highlights do not include all the information needed to use ANGIOMAX safely and effectively. See full prescribing information for ANGIOMAX. ANGIOMAX (bivalirudin) for injection, for intravenous use Initial U.S. Approval: 2000prescriptionHuman PrescriptionCardinal HealthREPACK2011-10-111551542275
37f3b2717-056e-4edb-a9b0-a63efa008d2b (view SPL)These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION.BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000prescriptionHuman PrescriptionHospira, Inc.2015-08-312004098300
4911cd48f-01ea-4dec-b30c-95e7e0ea9d2a (view SPL)These highlights do not include all the information needed to use Angiomax safely and effectively. See full prescribing information for Angiomax. ANGIOMAX (bivalirudin) for injection, for intravenous use Initial U.S. Approval: 2000prescriptionHuman PrescriptionThe Medicines CompanyANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK, STERILIZE2015-07-0816652930001
59f8f693d-e3bd-449f-0db2-4bb77d6c993c (view SPL)These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, ADD-Vantage Vial, for intravenous use Initial U.S. Approval: 2000prescriptionHuman PrescriptionHospira, Inc.2015-07-281004098300
6ce56f806-7845-429d-a1ce-c2dbf79b22eb (view SPL)These highlights do not include all the information needed to use Bivalirudin safely and effectively. See full prescribing information for Bivalirudin. Bivalirudin for injection, for intravenous use Initial U.S. Approval: 2000prescriptionHuman PrescriptionSandoz IncANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK, STERILIZE2015-07-081007813158

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