MedPath
FDA Approval

Dobutamine Hydrochloride

January 25, 2011

HUMAN PRESCRIPTION DRUG LABEL

Dobutamine(400 mg in 100 mL)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products (1)

Dobutamine Hydrochloride

54868-5777

NDA020201

NDA (C73594)

INTRAVENOUS

January 25, 2011

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