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FDA Approval

Isoproterenol hydrochloride

CompanyKVK-Tech, Inc. (DUNS: 173360061)

Effective Date

September 12, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Isoprenaline(0.2 mg in 1 mL)

Products (1)

Isoproterenol hydrochloride

NDC Product Code

10702-364

Application Number

ANDA215542

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

September 12, 2023

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

IsoprenalineActive

Code: DIA2A74855Class: ACTIBQuantity: 0.2 mg in 1 mL

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