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FDA Approval

Albuterol Sulfate

CompanyAsclemed USA, Inc. (DUNS: 059888437)

Effective Date

October 16, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Salbutamol(2.5 mg in 3 mL)

Manufacturing Establishments (1)

ASCLEMED USA INC. DBA ENOVACHEM

Labeler

Asclemed USA, Inc.

DUNS Number

059888437

Products (1)

Albuterol Sulfate

NDC Product Code

76420-087

Application Number

ANDA074880

Marketing Category

ANDA (C73584)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

October 16, 2020

Ingredients

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SULFURIC ACIDInactive

Code: O40UQP6WCFClass: IACT

SalbutamolActive

Code: 021SEF3731Class: ACTIMQuantity: 2.5 mg in 3 mL

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