FDA.reportPublic FDA data

Application 018132

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION40MG/MLYesYes
002DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION80MG/100MLYesYes
003DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION160MG/100MLYesYes
004DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION80MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9981Dopamine HydrochlorideDopamine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9981Dopamine HydrochlorideDopamine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9981Dopamine HydrochlorideDopamine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9982Dopamine HydrochlorideDopamine HydrochlorideHenry Schein, Inc.NDACurrent
0404-9982Dopamine HydrochlorideDopamine HydrochlorideHenry Schein, Inc.NDACurrent
0409-5820DOPamine HydrochlorideDopamine HydrochlorideHospira, Inc.NDACurrent
0409-5820DOPamine HydrochlorideDopamine HydrochlorideHospira, Inc.NDACurrent
0409-5820DOPamine HydrochlorideDopamine HydrochlorideHospira, Inc.NDACurrent
0409-9104DOPamine HydrochlorideDopamine HydrochlorideHospira, Inc.NDACurrent
0409-9104DOPamine HydrochlorideDopamine HydrochlorideHospira, Inc.NDACurrent
0409-9104DOPamine HydrochlorideDopamine HydrochlorideHospira, Inc.NDACurrent
51662-1220DOPAMINE HCIDOPAMINE HCIHF Acquisition Co. LLC, DBA Health FirstNDACurrent
51662-1220DOPAMINE HCIDOPAMINE HCIHF Acquisition Co. LLC, DBA Health FirstNDACurrent
51662-1220DOPAMINE HCIDOPAMINE HCIHF Acquisition Co. LLC, DBA Health FirstNDACurrent
51662-1220DOPAMINE HCIDOPAMINE HCIHF Acquisition Co. LLC, DBA Health FirstNDACurrent
51662-1291DOPAMINE HCIDOPAMINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1291DOPAMINE HCIDOPAMINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1291DOPAMINE HCIDOPAMINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1291DOPAMINE HCIDOPAMINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1291DOPAMINE HCIDOPAMINE HCIHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-104Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-104Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-104Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-104Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables & Vaccines, IncNDACurrent
52584-820Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables and Vaccines, Inc.NDACurrent
52584-820Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables and Vaccines, Inc.NDACurrent
52584-820Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables and Vaccines, Inc.NDACurrent
52584-820Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables and Vaccines, Inc.NDACurrent
52584-820Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables and Vaccines, Inc.NDACurrent
52584-820Dopamine HydrochlorideDopamine HydrochlorideGeneral Injectables and Vaccines, Inc.NDACurrent
55154-4735DOPamine HydrochlorideDopamine HydrochlorideCardinal HealthNDACurrent
71872-7066DOPamine HydrochlorideDopamine HydrochlorideMedical Purchasing Solutions, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75411SUPPL 2023-09-13
75407SUPPL 2023-09-12
849SUPPL2014-05-19
33439SUPPL2014-05-15