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FDA Approval

Albuterol Sulfate

CompanyNuCare Pharmaceuticals,Inc. (DUNS: 010632300)

Effective Date

March 15, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Salbutamol(0.83 mg in 1 mL)

Manufacturing Establishments (1)

NuCare Pharmaceuticals,Inc.

Labeler

NuCare Pharmaceuticals,Inc.

DUNS Number

010632300

Products (1)

Albuterol Sulfate

NDC Product Code

68071-2656

Application Number

ANDA207857

Marketing Category

ANDA (C73584)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

March 15, 2022

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULRClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SalbutamolActive

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

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

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