MedPath
FDA Approval

Dobutamine Hydrochloride in Dextrose

September 8, 2023

HUMAN PRESCRIPTION DRUG LABEL

Dobutamine(400 mg in 100 mL)

Manufacturing Establishments (1)

Baxter Healthcare Corporation

Baxter Healthcare Corporation

194684502

Products (3)

Dobutamine Hydrochloride in Dextrose

0338-1077

NDA020255

NDA (C73594)

INTRAVENOUS

September 8, 2023

Code: 0WR771DJXVClass: ACTIMQuantity: 400 mg in 100 mL
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083GClass: IACTQuantity: 5 g in 100 mL
SODIUM BISULFITEInactive
Code: TZX5469Z6IClass: IACTQuantity: 0.5 meq in 100 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Dobutamine Hydrochloride in Dextrose

0338-1075

NDA020255

NDA (C73594)

INTRAVENOUS

September 8, 2023

SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM BISULFITEInactive
Code: TZX5469Z6IClass: IACTQuantity: 0.5 meq in 100 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Code: 0WR771DJXVClass: ACTIMQuantity: 200 mg in 100 mL
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083GClass: IACTQuantity: 5 g in 100 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

Dobutamine Hydrochloride in Dextrose

0338-1073

NDA020255

NDA (C73594)

INTRAVENOUS

September 8, 2023

Code: 0WR771DJXVClass: ACTIMQuantity: 100 mg in 100 mL
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083GClass: IACTQuantity: 5 g in 100 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM BISULFITEInactive
Code: TZX5469Z6IClass: IACTQuantity: 0.5 meq in 100 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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