MedPath
FDA Approval

esmolol hydrochloride

July 24, 2018

HUMAN PRESCRIPTION DRUG LABEL

Esmolol(10 mg in 1 mL)

Products (2)

esmolol hydrochloride

25021-308

ANDA207107

ANDA (C73584)

INTRAVENOUS

July 24, 2018

EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 10 mg in 1 mL
acetic acidInactive
Code: Q40Q9N063PClass: IACT
sodium acetateInactive
Code: 4550K0SC9BClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT

esmolol hydrochloride

25021-309

ANDA207107

ANDA (C73584)

INTRAVENOUS

July 24, 2018

sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 20 mg in 1 mL
sodium acetateInactive
Code: 4550K0SC9BClass: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
acetic acidInactive
Code: Q40Q9N063PClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
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