ibutilide Injectable Solution

Brand(s)
Corvert
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2014-01-07)
Oldest Current Product
1995-12-28
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\IBUTILIDE
FDAOB
INJECTION\INJECTION\IBUTILIDE FUMARATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\IBUTILIDE FUMARATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\IBUTILIDE

product(s) by strength(s)

ibutilide fumarate 0.1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000093794CorvertNDAPharmacia And Upjohn Company1995-12-28IBUTILIDE FUMARATEINTRAVENOUSINJECTION, SOLUTIONNDA0204912428969a-7431-4e94-9503-ad5c680e2ea4, 3678cc63-b46c-4d5f-bfbe-65dea1d158ce, b7d717ed-022d-4459-b5e6-098c2a8b7427

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1101390705ANDAGeneramedix Inc.2010-01-12IBUTILIDE FUMARATEINTRAVENOUSINJECTION, SOLUTIONANDA0909242c833457-0409-4fb8-9363-d465bc5ee2fe
2674570366ANDAMylan Institutional Llc2010-01-11IBUTILIDE FUMARATEINTRAVENOUSINJECTION, SOLUTIONANDA090643c25d21e7-6136-4a7a-b139-12f53116fc3d

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA090240IBUTILIDE FUMARATELUITPOLD PHARMACEUTICALS INC2010-01-11ANDA090240_001
2ANDA090643IBUTILIDE FUMARATEMYLAN INSTITUTIONAL LLC2010-01-11ANDA090643_001
3ANDA090924IBUTILIDE FUMARATEMYLAN INSTITUTIONAL LLC2010-01-11ANDA090924_001
4NDA020491CORVERTPHARMACIA AND UPJOHN CO1995-12-28NDA020491_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA090240_001RXIBUTILIDE FUMARATE (0.1MG/ML)INJECTIONFalseAP2010-01-11IBUTILIDE FUMARATE
2ANDA090643_001RXIBUTILIDE FUMARATE (0.1MG/ML)INJECTIONFalseAP2010-01-11IBUTILIDE FUMARATE
3ANDA090924_001RXIBUTILIDE FUMARATE (0.1MG/ML)INJECTIONFalseAP2010-01-11IBUTILIDE FUMARATE
4NDA020491_001RXIBUTILIDE FUMARATE (0.1MG/ML)INJECTIONTrueAP1995-12-28CORVERT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12428969a-7431-4e94-9503-ad5c680e2ea4 (view SPL)Corvert ibutilide fumarate injectionprescriptionHuman PrescriptionPharmacia And Upjohn CompanyAPI MANUFACTURE, MANUFACTURE, PACK2012-09-042000093794
22c833457-0409-4fb8-9363-d465bc5ee2fe (view SPL)prescriptionHuman PrescriptionGeneramedix Inc.manufacture2010-01-121101390705
33678cc63-b46c-4d5f-bfbe-65dea1d158ce (view SPL)Corvert ibutilide fumarate injectionprescriptionHuman PrescriptionPharmacia And Upjohn CompanyAPI MANUFACTURE, MANUFACTURE, PACK2013-02-043000093794
4b7d717ed-022d-4459-b5e6-098c2a8b7427 (view SPL)Corvert ibutilide fumarate injectionprescriptionHuman PrescriptionPharmacia And Upjohn CompanyAPI MANUFACTURE, MANUFACTURE, PACK2014-01-074000093794
5c25d21e7-6136-4a7a-b139-12f53116fc3d (view SPL)IBUTILIDE FUMARATE INJECTIONprescriptionHuman PrescriptionMylan Institutional Llc2012-10-315674570366

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