FDA.reportPublic FDA data

Application 018826

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION80MG/100MLYesYes
002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION160MG/100MLYesYes
003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION320MG/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7809Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7809Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7809Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7809Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7810Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7810Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7810Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
0409-7810Dopamine Hydrochloride in DextroseDopamine Hydrochloride in DextroseHospira, Inc.NDACurrent
51662-1316DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1316DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1316DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1316DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1458DOPAMINE HCI IN 5% DEXTROSEDOPAMINE HCI IN 5% DEXTROSEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1458DOPAMINE HCI IN 5% DEXTROSEDOPAMINE HCI IN 5% DEXTROSEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82471SUPPL 2025-06-06
82468SUPPL 2025-06-05
67414SUPPL2021-05-05
67389SUPPL2021-05-04
1097SUPPL2014-05-19
33614SUPPL2014-05-15
40827SUPPL2003-07-28
16061SUPPL2003-04-03