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FDA Approval

albuterol sulfate

CompanyPadagis Israel Pharmaceuticals Ltd (DUNS: 600093611)

Effective Date

December 1, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Salbutamol(90 ug in 1 1)

Products (1)

albuterol sulfate

NDC Product Code

45802-088

Application Number

ANDA203760

Marketing Category

ANDA (C73584)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

December 1, 2021

Ingredients

SalbutamolActive

Code: 021SEF3731Class: ACTIMQuantity: 90 ug in 1 1

NORFLURANEInactive

Code: DH9E53K1Y8Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

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