MedPath
FDA Approval

Esmolol Hydrochloride

November 6, 2007

HUMAN PRESCRIPTION DRUG LABEL

Esmolol(10 mg in 1 mL)

Manufacturing Establishments (2)

Lancaster Laboratories

West Ward Pharmaceutical Corporation

069777290

West Ward Pharmaceutical Corporation, Cherry Hill New Jersey

West Ward Pharmaceutical Corporation

946499746

Products (1)

Esmolol Hydrochloride

0641-2965

NDA019386

NDA (C73594)

INTRAVENOUS

November 6, 2007

ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.9 mg in 1 mL
EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 10 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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