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FDA Approval

Albuterol Sulfate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
May 30, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Salbutamol(2.5 mg in 3 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Medical Purchasing Solutions, LLC

Medical Purchasing Solutions, LLC

601458529

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Albuterol Sulfate

Product Details

NDC Product Code
71872-7054
Application Number
ANDA077839
Marketing Category
ANDA (C73584)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
May 30, 2023
Code: 021SEF3731Class: ACTIMQuantity: 2.5 mg in 3 mL
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