MedPath
FDA Approval

Dobutamine in Dextrose

November 3, 2021

HUMAN PRESCRIPTION DRUG LABEL

Dobutamine(400 mg in 100 mL)

Manufacturing Establishments (1)

Hospira, Inc.

Hospira, Inc.

827731089

Products (3)

Dobutamine in Dextrose

0409-3724

NDA020201

NDA (C73594)

INTRAVENOUS

November 3, 2021

DEXTROSE MONOHYDRATEInactive
Code: LX22YL083GClass: IACTQuantity: 5 g in 100 mL
Code: 0WR771DJXVClass: ACTIMQuantity: 400 mg in 100 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 25 mg in 100 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 10 mg in 100 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

Dobutamine in Dextrose

0409-2346

NDA020201

NDA (C73594)

INTRAVENOUS

November 3, 2021

Code: 0WR771DJXVClass: ACTIMQuantity: 100 mg in 100 mL
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083GClass: IACTQuantity: 5 g in 100 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 25 mg in 100 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 10 mg in 100 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

Dobutamine in Dextrose

0409-2347

NDA020201

NDA (C73594)

INTRAVENOUS

November 3, 2021

Code: 0WR771DJXVClass: ACTIMQuantity: 200 mg in 100 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083GClass: IACTQuantity: 5 g in 100 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 25 mg in 100 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 10 mg in 100 mL
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