FDA.reportPublic FDA data

Application 020201

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MG BASE/100MLYesYes
002DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 100MG BASE/100MLYesYes
003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 50MG BASE/100MLYesYes
006DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 400MG BASE/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-2346Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-2346Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-2346Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-2346Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-2346Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-2346Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-2346Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-2347Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-2347Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-2347Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-2347Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-2347Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-2347Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-2347Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-3724Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-3724Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-3724Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-3724Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-3724Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-3724Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
0409-3724Dobutamine in DextroseDobutamine in DextroseHospira, Inc.NDACurrent
51662-1330DOBUTAMINEDOBUTAMINEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1330DOBUTAMINEDOBUTAMINEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1330DOBUTAMINEDOBUTAMINEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85810SUPPL 2026-05-04
85808SUPPL 2026-05-04
78788SUPPL 2024-06-13
78782SUPPL 2024-06-13
58965SUPPL2019-06-04
58873SUPPL2019-05-29
24563SUPPL2016-06-01
12315SUPPL2016-06-01
24562SUPPL2001-04-11