MedPath
FDA Approval

Levalbuterol

February 17, 2020

HUMAN PRESCRIPTION DRUG LABEL

Levosalbutamol(1.25 mg in 3 mL)

Products (3)

Levalbuterol

0378-9692

ANDA203653

ANDA (C73584)

RESPIRATORY (INHALATION)

November 28, 2017

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

Levalbuterol

0378-9691

ANDA203653

ANDA (C73584)

RESPIRATORY (INHALATION)

November 28, 2017

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

Levalbuterol

0378-9690

ANDA203653

ANDA (C73584)

RESPIRATORY (INHALATION)

November 28, 2017

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