Dobutamine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2014-04-01)
Oldest Current Product
1993-09-23
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\DOBUTAMINE
FDAOB
INJECTION\INJECTION\DOBUTAMINE HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DOBUTAMINE HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DOBUTAMINE HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\DOBUTAMINE HYDROCHLORIDE
INTRAVENOUS\INJECTION\DOBUTAMINE HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DOBUTAMINE
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DOBUTAMINE
INTRAVENOUS\INJECTION, SOLUTION\DOBUTAMINE
INTRAVENOUS\INJECTION\DOBUTAMINE

product(s) by strength(s)

dobutamine 0.5 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1003381071NDABaxter Healthcare Corporation1993-09-272008-12-31DOBUTAMINE HYDROCHLORIDEINTRAVENOUSINJECTIONNDA0202556b17b98b-e06d-42ed-925f-69aa2699dead

dobutamine 1 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003381073NDABaxter Healthcare Corporation1993-09-27DOBUTAMINE HYDROCHLORIDEINTRAVENOUSINJECTIONNDA0202556b17b98b-e06d-42ed-925f-69aa2699dead

dobutamine 12.5 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092025ANDAHospira, Inc.1995-02-16DOBUTAMINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA074292cb842dc2-fb15-48f9-e4b1-ea4280db0199
2004092344ANDAHospira, Inc.1993-11-29DOBUTAMINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA074086dc537761-d5f4-488d-24ab-b2bcd2b17b7a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840048ANDAGeneral Injecatables & Vaccines, Inc2014-11-10DOBUTAMINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION004092025ANDA074292e0c86f73-38ec-44ad-934b-f48777c41c55
2525840051ANDAGeneral Injecatables & Vaccines, Inc2010-03-01DOBUTAMINE HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION553900560ANDA074277d79db1b1-e04b-46f4-ba7c-ed5bde835463
3548685717ANDAPhysicians Total Care, Inc.2006-12-11DOBUTAMINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION004092025ANDA074292a0882db1-2532-4b80-b753-68f013fe79e7

dobutamine 2 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003381075NDABaxter Healthcare Corporation1993-09-27DOBUTAMINE HYDROCHLORIDEINTRAVENOUSINJECTIONNDA0202556b17b98b-e06d-42ed-925f-69aa2699dead

dobutamine 4 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003381077NDABaxter Healthcare Corporation1993-09-23DOBUTAMINE HYDROCHLORIDEINTRAVENOUSINJECTIONNDA0202556b17b98b-e06d-42ed-925f-69aa2699dead

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685777NDAPhysicians Total Care, Inc.2007-06-13DOBUTAMINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION00409372432NDA020201c0dd68b3-20af-464d-b3ba-34eb886df6ae

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074086DOBUTAMINE HYDROCHLORIDEHOSPIRA INC1993-11-29ANDA074086_001
2ANDA074098DOBUTAMINE HYDROCHLORIDETrueIGI LABORATORIES INC1995-02-21ANDA074098_001
3ANDA074114DOBUTAMINE HYDROCHLORIDETrueWATSON LABORATORIES INC1993-11-30ANDA074114_001
4ANDA074206DOBUTAMINE HYDROCHLORIDETrueTEVA PARENTERAL MEDICINES INC1993-10-19ANDA074206_001
5ANDA074277DOBUTAMINE HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL1994-10-31ANDA074277_001
6ANDA074279DOBUTAMINE HYDROCHLORIDETrueWATSON LABORATORIES INC1998-02-18ANDA074279_001
7ANDA074292DOBUTAMINE HYDROCHLORIDEHOSPIRA WORLDWIDE, INC1995-02-16ANDA074292_001
8ANDA074381DOBUTAMINE HYDROCHLORIDETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1996-09-26ANDA074381_001
9ANDA074545DOBUTAMINE HYDROCHLORIDETrueLUITPOLD PHARMACEUTICALS INC1998-06-25ANDA074545_001
10ANDA074634DOBUTAMINE HYDROCHLORIDETrueHOSPIRA INC1996-09-27ANDA074634_001
11ANDA074995DOBUTAMINE HYDROCHLORIDETrueWATSON LABORATORIES INC1998-03-31ANDA074995_001
12NDA017820DOBUTREXTrueELI LILLY AND CONDA017820_002
13NDA020201DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERHOSPIRA INC1993-10-19NDA020201_001, NDA020201_002, NDA020201_003, NDA020201_006
14NDA020255DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP1993-10-19NDA020255_001, NDA020255_003, NDA020255_004, NDA020255_005
15NDA020269DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%TrueHOSPIRA INC1993-10-19NDA020269_001, NDA020269_002, NDA020269_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074086_001RXDOBUTAMINE HYDROCHLORIDE (EQ 12.5MG BASE/ML)INJECTIONFalseAP1993-11-29DOBUTAMINE HYDROCHLORIDE
2ANDA074098_001discontinuedDOBUTAMINE HYDROCHLORIDE (EQ 12.5MG BASE/ML)INJECTIONFalse1995-02-21DOBUTAMINE HYDROCHLORIDE
3ANDA074114_001discontinuedDOBUTAMINE HYDROCHLORIDE (EQ 12.5MG BASE/ML)INJECTIONFalse1993-11-30DOBUTAMINE HYDROCHLORIDE
4ANDA074206_001discontinuedDOBUTAMINE HYDROCHLORIDE (EQ 12.5MG BASE/ML)INJECTIONFalse1993-10-19DOBUTAMINE HYDROCHLORIDE
5ANDA074277_001RXDOBUTAMINE HYDROCHLORIDE (EQ 12.5MG BASE/ML)INJECTIONFalseAP1994-10-31DOBUTAMINE HYDROCHLORIDE
6ANDA074279_001discontinuedDOBUTAMINE HYDROCHLORIDE (EQ 12.5MG BASE/ML)INJECTIONFalse1998-02-18DOBUTAMINE HYDROCHLORIDE
7ANDA074292_001RXDOBUTAMINE HYDROCHLORIDE (EQ 12.5MG BASE/ML)INJECTIONTrueAP1995-02-16DOBUTAMINE HYDROCHLORIDE
8ANDA074381_001discontinuedDOBUTAMINE HYDROCHLORIDE (EQ 12.5MG BASE/ML)INJECTIONFalse1996-09-26DOBUTAMINE HYDROCHLORIDE
9ANDA074545_001discontinuedDOBUTAMINE HYDROCHLORIDE (EQ 12.5MG BASE/ML)INJECTIONFalse1998-06-25DOBUTAMINE HYDROCHLORIDE
10ANDA074634_001discontinuedDOBUTAMINE HYDROCHLORIDE (EQ 1.25GM BASE/100ML)INJECTIONFalse1996-09-27DOBUTAMINE HYDROCHLORIDE
11ANDA074995_001discontinuedDOBUTAMINE HYDROCHLORIDE (EQ 12.5MG BASE/ML)INJECTIONFalse1998-03-31DOBUTAMINE HYDROCHLORIDE
12NDA017820_002discontinuedDOBUTAMINE HYDROCHLORIDE (EQ 12.5MG BASE/ML)INJECTIONFalseDOBUTREX
13NDA020201_001RXDOBUTAMINE HYDROCHLORIDE (EQ 200MG BASE/100ML)INJECTIONTrueAP1993-10-19DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
14NDA020201_002RXDOBUTAMINE HYDROCHLORIDE (EQ 100MG BASE/100ML)INJECTIONTrueAP1993-10-19DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
15NDA020201_003RXDOBUTAMINE HYDROCHLORIDE (EQ 50MG BASE/100ML)INJECTIONTrueAP1993-10-19DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
16NDA020201_006RXDOBUTAMINE HYDROCHLORIDE (EQ 400MG BASE/100ML)INJECTIONTrueAP1994-07-07DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
17NDA020255_001RXDOBUTAMINE HYDROCHLORIDE (EQ 50MG BASE/100ML)INJECTIONTrueAP1993-10-19DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
18NDA020255_003RXDOBUTAMINE HYDROCHLORIDE (EQ 100MG BASE/100ML)INJECTIONTrueAP1993-10-19DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
19NDA020255_004RXDOBUTAMINE HYDROCHLORIDE (EQ 200MG BASE/100ML)INJECTIONTrueAP1993-10-19DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
20NDA020255_005RXDOBUTAMINE HYDROCHLORIDE (EQ 400MG BASE/100ML)INJECTIONTrueAP1993-10-19DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
21NDA020269_001discontinuedDOBUTAMINE HYDROCHLORIDE (EQ 50MG BASE/100ML)INJECTIONFalse1993-10-19DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
22NDA020269_002discontinuedDOBUTAMINE HYDROCHLORIDE (EQ 100MG BASE/100ML)INJECTIONFalse1993-10-19DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
23NDA020269_003discontinuedDOBUTAMINE HYDROCHLORIDE (EQ 200MG BASE/100ML)INJECTIONFalse1993-10-19DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
16b17b98b-e06d-42ed-925f-69aa2699dead (view SPL)DOBUTamine Hydrochloride in 5% Dextrose Injection in Plastic ContainerVIAFLEX Plus ContainerprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-04-018003381071, 003381073, 003381075, 003381077
29943a961-3b50-4847-8a84-d8414ce38daa (view SPL)DOBUTaminein 5% Dextrose Injection, USPprescriptionHuman PrescriptionHospira, Inc.2013-11-2611004092346, 004092347, 004093724
3a0882db1-2532-4b80-b753-68f013fe79e7 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-01-251548685717
4c0dd68b3-20af-464d-b3ba-34eb886df6ae (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-01-251548685777
5cb842dc2-fb15-48f9-e4b1-ea4280db0199 (view SPL)DOBUTamine INJECTION, USPprescriptionHuman PrescriptionHospira, Inc.2012-07-313004092025
6d79db1b1-e04b-46f4-ba7c-ed5bde835463 (view SPL)Dobutamine 250 mg Injection, USP 20 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-03-152525840051
7dc537761-d5f4-488d-24ab-b2bcd2b17b7a (view SPL)DOBUTamineINJECTION, USPprescriptionHuman PrescriptionHospira, Inc.2014-06-043004092344
8e0c86f73-38ec-44ad-934b-f48777c41c55 (view SPL)DOBUTAMINEprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2014-10-151525840048

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