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FDA Approval

Albuterol

CompanyBryant Ranch Prepack (DUNS: 171714327)

Effective Date

November 27, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Salbutamol(4 mg in 1 1)

Registrants (1)

Bryant Ranch Prepack

DUNS Number

171714327

Manufacturing Establishments (1)

Bryant Ranch Prepack

Labeler

Bryant Ranch Prepack

Registrant

Bryant Ranch Prepack

DUNS Number

171714327

Products (1)

Albuterol

NDC Product Code

63629-2611

Application Number

ANDA207046

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 3, 2022

Ingredients

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98GClass: IACT

SalbutamolActive

Code: 021SEF3731Class: ACTIMQuantity: 4 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

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