Isoproterenol Injection

Brand(s)
Isuprel
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2013-09-10)
Oldest Current Product
2010-03-01
License(s)
NDA
RxNORM
INJECTION\ISOPROTERENOL
FDAOB
INJECTION\INJECTION\ISOPROTERENOL HYDROCHLORIDE\rdfq
SPL Active
INTRACARDIAC\INJECTION, SOLUTION\ISOPROTERENOL HYDROCHLORIDE
SPL Moiety
INTRACARDIAC\INJECTION, SOLUTION\ISOPROTERENOL

product(s) by strength(s)

isoproterenol hydrochloride 0.2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091410IsuprelNDAHospira, Inc.2012-06-18ISOPROTERENOL HYDROCHLORIDEINTRACARDIACINJECTION, SOLUTIONNDA010515c4288d64-4f76-44f8-d097-4bd3955f5676
2004091442IsuprelNDAHospira, Inc.2013-03-21ISOPROTERENOL HYDROCHLORIDEINTRACARDIACINJECTION, SOLUTIONNDA010515a58f95fa-18f9-4938-8e3f-f33244f68298

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840021NDAGeneral Injecatables & Vaccines, Inc2010-03-01ISOPROTERENOL HYDROCHLORIDEINTRACARDIACINJECTION, SOLUTION004091410NDA010515c099ecdc-d636-43d4-8298-eb43073c41a9
2551546988IsuprelNDACardinal Health2012-06-18ISOPROTERENOL HYDROCHLORIDEINTRACARDIACINJECTION, SOLUTION004091410NDA01051520062322-f9db-4c9b-9da2-7608468f62c9

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544729IsuprelNDACardinal Health2012-06-18ISOPROTERENOL HYDROCHLORIDEINTRACARDIACINJECTION, SOLUTION004091410NDA0105157db5c78c-0463-4ec9-b237-33f13e2f6460

application(s)

#idtitledeprecatedapplicantapproved drug
1ANDA083283ISOPROTERENOL HYDROCHLORIDETrueHOSPIRA INCANDA083283_001
2ANDA083346ISOPROTERENOL HYDROCHLORIDETrueHOSPIRA INCANDA083346_001
3ANDA083431ISOPROTERENOL HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTSANDA083431_001
4ANDA083486ISOPROTERENOL HYDROCHLORIDETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CAREANDA083486_001
5ANDA083724ISOPROTERENOL HYDROCHLORIDETrueINTERNATIONAL MEDICATION SYSTEMANDA083724_001
6NDA010515ISUPRELHOSPIRA INCNDA010515_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapplication
1ANDA083283_001discontinuedISOPROTERENOL HYDROCHLORIDE (0.02MG/ML)INJECTIONFalseISOPROTERENOL HYDROCHLORIDE
2ANDA083346_001discontinuedISOPROTERENOL HYDROCHLORIDE (0.2MG/ML)INJECTIONFalseISOPROTERENOL HYDROCHLORIDE
3ANDA083431_001discontinuedISOPROTERENOL HYDROCHLORIDE (0.2MG/ML)INJECTIONFalseISOPROTERENOL HYDROCHLORIDE
4ANDA083486_001discontinuedISOPROTERENOL HYDROCHLORIDE (0.2MG/ML)INJECTIONFalseISOPROTERENOL HYDROCHLORIDE
5ANDA083724_001discontinuedISOPROTERENOL HYDROCHLORIDE (0.2MG/ML)INJECTIONFalseISOPROTERENOL HYDROCHLORIDE
6NDA010515_001RXISOPROTERENOL HYDROCHLORIDE (0.2MG/ML)INJECTIONTrueISUPREL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
120062322-f9db-4c9b-9da2-7608468f62c9 (view SPL)ISUPRELprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-081551546988
2743515bf-af8c-4014-9e4a-bf6972811ea1 (view SPL)IsuprelprescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2015-02-011001874330
37db5c78c-0463-4ec9-b237-33f13e2f6460 (view SPL)ISUPRELprescriptionHuman PrescriptionCardinal HealthREPACK2013-04-231551544729
4a58f95fa-18f9-4938-8e3f-f33244f68298 (view SPL)IsuprelTMprescriptionHuman PrescriptionHospira, Inc.2013-09-102004091442
5abf5e543-36e8-416e-b053-483ddbf4e568 (view SPL)IsuprelTMprescriptionHuman PrescriptionMarathon Pharmaceuticals, Llc2013-11-182429980402
6c099ecdc-d636-43d4-8298-eb43073c41a9 (view SPL)Isuprel 1:5000 (Isoproterenol Hydrochloride) 0.2 mg/mL Injection, USP 1mL Single Dose AmpuleprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-232525840021
7c4288d64-4f76-44f8-d097-4bd3955f5676 (view SPL)ISUPRELprescriptionHuman PrescriptionHospira, Inc.2012-06-1812004091410

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