MedPath
FDA Approval

Esmolol Hydrochloride

July 19, 2023

HUMAN PRESCRIPTION DRUG LABEL

Esmolol(20 mg in 1 mL)

Manufacturing Establishments (1)

Amneal Injectables Private Limited

Amneal Pharmaceuticals LLC

854377396

Products (2)

Esmolol Hydrochloride

70121-1717

ANDA216603

ANDA (C73584)

INTRAVENOUS

July 18, 2023

EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 20 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2.8 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.546 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 4.1 mg in 1 mL

Esmolol Hydrochloride

70121-1716

ANDA216603

ANDA (C73584)

INTRAVENOUS

July 18, 2023

HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 10 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.546 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.9 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2.8 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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