FDA.reportPublic FDA data

Application 020255

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 50MG BASE/100MLYesYes
003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 100MG BASE/100MLYesYes
004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MG BASE/100MLYesYes
005DOBUTAMINE 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
0338-1073Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1073Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1073Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporaNDACurrent
0338-1073Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1073Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1075Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1075Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporaNDACurrent
0338-1075Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1075Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1075Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1077Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1077Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1077Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-1077Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporaNDACurrent
0338-1077Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideBaxter Healthcare CorporationNDACurrent
50090-4562Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideA-S Medication SolutionsNDACurrent
50090-4562Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideA-S Medication SolutionsNDACurrent
50090-4562Dobutamine Hydrochloride in DextroseDobutamine HydrochlorideA-S Medication SolutionsNDACurrent
51662-1566DOBUTAMINE HYDROCHLORIDEDOBUTAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75385SUPPL 2023-09-11
75277SUPPL 2023-08-24
66069SUPPL2021-02-03
58257SUPPL2019-04-08
58131SUPPL2019-03-28
24667SUPPL2013-04-23
12377SUPPL2013-04-19
2253SUPPL2012-03-12
24666SUPPL2003-07-28
2252SUPPL2003-07-28
20558SUPPL2000-06-14