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FDA Approval

DEXAMETHASONE SODIUM PHOSPHATE

CompanyMedical Purchasing Solutions, LLC (DUNS: 601458529)

Effective Date

May 3, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Dexamethasone(10 mg in 1 mL)

Manufacturing Establishments (1)

Medical Purchasing Solutions, LLC

Labeler

Medical Purchasing Solutions, LLC

DUNS Number

601458529

Products (1)

DEXAMETHASONE SODIUM PHOSPHATE

NDC Product Code

71872-7205

Application Number

ANDA211036

Marketing Category

ANDA (C73584)

Route of Administration

INTRAMUSCULAR, INTRAVENOUS

Effective Date

May 3, 2023

Ingredients

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACTQuantity: 13.5 mg in 1 mL

DexamethasoneActive

Code: AI9376Y64PClass: ACTIRQuantity: 10 mg in 1 mL

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACTQuantity: 10 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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