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FDA Approval

Levalbuterol

CompanyTeva Pharmaceuticals USA, Inc. (DUNS: 001627975)

Effective Date

January 31, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Levosalbutamol(1.25 mg in 0.5 mL)

Products (1)

Levalbuterol

NDC Product Code

0093-4147

Application Number

ANDA200875

Marketing Category

ANDA (C73584)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

January 31, 2019

Ingredients

LevosalbutamolActive

Code: WDQ1526QJMClass: ACTIMQuantity: 1.25 mg in 0.5 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

SULFURIC ACIDInactive

Code: O40UQP6WCFClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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