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FDA Approval

Albuterol Sulfate

CompanyPreferred Pharmaceuticals Inc. (DUNS: 791119022)

Effective Date

July 24, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Salbutamol(0.83 mg in 1 mL)

Registrants (1)

Preferred Pharmaceuticals Inc.

DUNS Number

791119022

Manufacturing Establishments (1)

Preferred Pharmaceuticals Inc.

Labeler

Preferred Pharmaceuticals Inc.

Registrant

Preferred Pharmaceuticals Inc.

DUNS Number

791119022

Products (1)

Albuterol Sulfate

NDC Product Code

68788-8492

Application Number

ANDA207857

Marketing Category

ANDA (C73584)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

July 24, 2023

Ingredients

SalbutamolActive

Code: 021SEF3731Class: ACTIMQuantity: 0.83 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULRClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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