FDA.reportPublic FDA data

Application 019615

Type
NDA
Sponsor
BAXTER HLTHCARE

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
004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDEINJECTABLE;INJECTION640MG/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-1005Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1005Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1005Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1005Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1005Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1007Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1007Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1007Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1007Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1007Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1009Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1009Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1009Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1009Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1009Dopamine Hydrochloride and DextroseDopamine HydrochlorideBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65591SUPPL2020-12-15
49079SUPPL2017-07-25
49055SUPPL2017-07-25
11563SUPPL2012-06-18
1418SUPPL2012-06-18
17485SUPPL2012-03-15
17483SUPPL2007-07-05
17484SUPPL2002-06-20
20266SUPPL2001-04-17
17482SUPPL2001-04-17