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FDA Approval

Albuterol Sulfate

CompanyRitedose Pharmaceuticals, LLC (DUNS: 968062294)

Effective Date

December 20, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Salbutamol(2.5 mg in 3 mL)

Manufacturing Establishments (1)

The Ritedose Corporation

Labeler

Ritedose Pharmaceuticals, LLC

DUNS Number

837769546

Products (1)

Albuterol Sulfate

NDC Product Code

76204-200

Application Number

ANDA077839

Marketing Category

ANDA (C73584)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

December 20, 2023

Ingredients

SalbutamolActive

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

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