MedPath
FDA Approval

ISOPROTERENOL HYDROCHLORIDE

July 16, 2018

HUMAN PRESCRIPTION DRUG LABEL

Isoprenaline(0.2 mg in 1 mL)

Registrants (1)

Manufacturing Establishments (1)

Amphastar Pharmaceuticals, Inc.

Amphastar Pharmaceuticals, Inc.

Amphastar Pharmaceuticals, Inc.

024736733

Products (2)

ISOPROTERENOL HYDROCHLORIDE

0548-9502

ANDA210106

ANDA (C73584)

INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRACARDIAC

July 16, 2018

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

ISOPROTERENOL HYDROCHLORIDE

0548-9501

ANDA210106

ANDA (C73584)

INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRACARDIAC

July 16, 2018

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