MedPath
FDA Approval

Isoproterenol Hydrochloride

January 2, 2024

HUMAN PRESCRIPTION DRUG LABEL

Isoprenaline(0.2 mg in 1 mL)

Registrants (1)

Manufacturing Establishments (1)

Emcure Pharmaceuticals Limited

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

AVET LIFESCIENCES PRIVATE LIMITED

675467924

Products (2)

Isoproterenol Hydrochloride

23155-660

ANDA212189

ANDA (C73584)

INTRAVENOUS

November 21, 2023

Code: DIA2A74855Class: ACTIBQuantity: 0.2 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.2 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 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
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT

Isoproterenol Hydrochloride

23155-661

ANDA212189

ANDA (C73584)

INTRAVENOUS

November 21, 2023

SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: DIA2A74855Class: ACTIBQuantity: 0.2 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
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: 2.5 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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