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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
February 6, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Salbutamol(90 ug in 1 1)

Manufacturing Establishments1

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

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

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

Albuterol Sulfate HFA

Product Details

NDC Product Code
50090-4138
Application Number
NDA021457
Marketing Category
NDA authorized generic (C73605)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
January 31, 2023
Code: 021SEF3731Class: ACTIMQuantity: 90 ug in 1 1
NORFLURANEInactive
Code: DH9E53K1Y8Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
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