MedPath
FDA Approval

Isoproterenol Hydrochloride

June 1, 2021

HUMAN PRESCRIPTION DRUG LABEL

Isoprenaline(0.2 mg in 1 mL)

Manufacturing Establishments (1)

Indoco Remedies Limited

Amring Pharmaceuticals Inc.

915851870

Products (2)

Isoproterenol Hydrochloride

69918-731

ANDA211237

ANDA (C73584)

INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRACARDIAC

May 28, 2021

Code: DIA2A74855Class: ACTIBQuantity: 0.2 mg in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 2.5 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7.0 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.2 mg in 1 mL
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACTQuantity: 2.07 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

Isoproterenol Hydrochloride

69918-735

ANDA211237

ANDA (C73584)

INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRACARDIAC

May 28, 2021

Code: DIA2A74855Class: ACTIBQuantity: 0.2 mg in 1 mL
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACTQuantity: 2.07 mg in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 2.5 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7.0 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.2 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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