Bumetanide Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2014-07-23)
Oldest Current Product
1994-10-31
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\BUMETANIDE
FDAOB
INJECTION\INJECTION\BUMETANIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\BUMETANIDE
INTRAMUSCULAR\INJECTION\BUMETANIDE
INTRANODAL\INJECTION, SOLUTION\BUMETANIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\BUMETANIDE
INTRAMUSCULAR\INJECTION\BUMETANIDE
INTRANODAL\INJECTION, SOLUTION\BUMETANIDE

product(s) by strength(s)

bumetanide 0.25 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091412ANDAHospira, Inc.1994-10-31, 2008-07-23BUMETANIDEINTRAMUSCULARINJECTION, SOLUTIONANDA074332bf9ff69a-3436-41c8-b6a2-749f041daf4b, e71daa68-2744-47da-64b4-0a725c2e8457
2006416007ANDAWest-Ward Pharmaceuticals Corp.2008-04-30BUMETANIDEINTRAMUSCULARINJECTIONANDA079196681b5e9d-e2c7-4f29-aaad-e06d4a528c11
3006416008ANDAWest-Ward Pharmaceuticals Corp.2008-04-30BUMETANIDEINTRAMUSCULARINJECTIONANDA079196681b5e9d-e2c7-4f29-aaad-e06d4a528c11
4006416161ANDAWest-Ward Pharmaceuticals Corp.2008-04-30BUMETANIDEINTRAMUSCULARINJECTIONANDA079196b5a68154-8003-4b80-81e2-e926524fb72c
5006416162ANDAWest-Ward Pharmaceuticals Corp.2008-04-30BUMETANIDEINTRAMUSCULARINJECTIONANDA079196b5a68154-8003-4b80-81e2-e926524fb72c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551540358ANDACardinal Health1995-03-01BUMETANIDEINTRAMUSCULARINJECTION553900500ANDA074441fc35f3c6-a8c4-4cb7-8188-8269cc24cad8
2551542851ANDACardinal Health2009-01-27BUMETANIDEINTRAMUSCULARINJECTION100190506ANDA07919600b71dc2-1851-4670-a48e-b4eb89d48d0b
3551544725ANDACardinal Health2011-11-16BUMETANIDEINTRAMUSCULARINJECTION, SOLUTION004091412ANDA074332c35aea66-17c7-47f5-8105-c33a53a26d5e
4551544728ANDACardinal Health2011-11-16BUMETANIDEINTRANODALINJECTION, SOLUTION004091412ANDA074332cf01d206-f19e-4ab4-ac76-2a1297dced72
5551544733ANDACardinal Health2011-11-16BUMETANIDEINTRAMUSCULARINJECTION, SOLUTION004091412ANDA074332168fe885-a19e-4007-a258-77b50b22bfb4

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074160BUMETANIDETrueHOSPIRA INC1997-10-30ANDA074160_001
2ANDA074332BUMETANIDEHOSPIRA INC1994-10-31ANDA074332_001
3ANDA074441BUMETANIDEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1995-01-27ANDA074441_001
4ANDA074613BUMETANIDETrueTEVA PARENTERAL MEDICINES INC1997-11-18ANDA074613_001
5ANDA079196BUMETANIDEEUROHEALTH INTERNATIONAL SARL2008-04-30ANDA079196_001
6NDA018226BUMEXTrueVALIDUS PHARMACEUTICALS INC1983-02-28NDA018226_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074160_001discontinuedBUMETANIDE (0.25MG/ML)INJECTIONFalse1997-10-30BUMETANIDE
2ANDA074332_001RXBUMETANIDE (0.25MG/ML)INJECTIONFalseAP1994-10-31BUMETANIDE
3ANDA074441_001RXBUMETANIDE (0.25MG/ML)INJECTIONTrueAP1995-01-27BUMETANIDE
4ANDA074613_001discontinuedBUMETANIDE (0.25MG/ML)INJECTIONFalse1997-11-18BUMETANIDE
5ANDA079196_001RXBUMETANIDE (0.25MG/ML)INJECTIONFalseAP2008-04-30BUMETANIDE
6NDA018226_001discontinuedBUMETANIDE (0.25MG/ML)INJECTIONFalse1983-02-28BUMEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100b71dc2-1851-4670-a48e-b4eb89d48d0b (view SPL)Bumetanide Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2012-01-312551542851
2168fe885-a19e-4007-a258-77b50b22bfb4 (view SPL)Bumetanide Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-07-292551544733
3681b5e9d-e2c7-4f29-aaad-e06d4a528c11 (view SPL)Bumetanide Injection, USP Rx OnlyprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2011-09-261006416007, 006416008
4b5a68154-8003-4b80-81e2-e926524fb72c (view SPL)Bumetanide Injection, USPRx ONLY NOVAPLUSprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2015-03-021006416161, 006416162
5bf9ff69a-3436-41c8-b6a2-749f041daf4b (view SPL)Bumetanide Injection, USPprescriptionHuman PrescriptionHospira, Inc.analysis, api manufacture, manufacture2014-07-231004091412
6c35aea66-17c7-47f5-8105-c33a53a26d5e (view SPL)Bumetanide Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-09-302551544725
7cf01d206-f19e-4ab4-ac76-2a1297dced72 (view SPL)Bumetanide Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-04-302551544728
8e71daa68-2744-47da-64b4-0a725c2e8457 (view SPL)Bumetanide Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-07-2311004091412
9fc35f3c6-a8c4-4cb7-8188-8269cc24cad8 (view SPL)BUMETANIDE INJECTION, USPprescriptionHuman PrescriptionCardinal HealthREPACK2012-01-312551540358

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