MedPath
FDA Approval

Levalbuterol

October 31, 2023

HUMAN PRESCRIPTION DRUG LABEL

Levosalbutamol(0.63 mg in 3 mL)

Manufacturing Establishments (1)

Eugia Pharma Specialities Limited

Aurobindo Pharma Limited

650498244

Products (3)

Levalbuterol

65862-944

ANDA207625

ANDA (C73584)

RESPIRATORY (INHALATION)

October 31, 2023

SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
NITROGENInactive
Code: N762921K75Class: IACT
Code: WDQ1526QJMClass: ACTIMQuantity: 0.63 mg in 3 mL

Levalbuterol

65862-943

ANDA207625

ANDA (C73584)

RESPIRATORY (INHALATION)

October 31, 2023

EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: WDQ1526QJMClass: ACTIMQuantity: 0.31 mg in 3 mL
NITROGENInactive
Code: N762921K75Class: IACT

Levalbuterol

65862-945

ANDA207625

ANDA (C73584)

RESPIRATORY (INHALATION)

October 31, 2023

EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
NITROGENInactive
Code: N762921K75Class: IACT
Code: WDQ1526QJMClass: ACTIMQuantity: 1.25 mg in 3 mL
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