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FDA Approval

Isoproterenol Hydrochloride

CompanySTI Pharma LLC (DUNS: 832714070)

Effective Date

October 3, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Isoprenaline(1 mg in 5 mL)

Manufacturing Establishments (1)

Immacule Lifesciences Private Limited

Labeler

STI Pharma LLC

DUNS Number

650694503

Products (1)

Isoproterenol Hydrochloride

NDC Product Code

54879-039

Application Number

ANDA215542

Marketing Category

ANDA (C73584)

Route of Administration

INTRACARDIAC, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Effective Date

October 4, 2022

Ingredients

IsoprenalineActive

Code: DIA2A74855Class: ACTIBQuantity: 1 mg in 5 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT

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