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FDA Approval

Levalbuterol

CompanyNuCare Pharmaceuticals,Inc. (DUNS: 010632300)

Effective Date

February 2, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Levosalbutamol(1.25 mg in 3 mL)

Manufacturing Establishments (1)

NuCare Pharmaceuticals,Inc.

Labeler

NuCare Pharmaceuticals,Inc.

DUNS Number

010632300

Products (1)

Levalbuterol

NDC Product Code

68071-2340

Application Number

ANDA207820

Marketing Category

ANDA (C73584)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

February 2, 2021

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SULFURIC ACIDInactive

Code: O40UQP6WCFClass: IACT

NITROGENInactive

Code: N762921K75Class: IACT

LevosalbutamolActive

Code: WDQ1526QJMClass: ACTIMQuantity: 1.25 mg in 3 mL

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