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FDA Product

fondaparinux sodium

Product approved by U.S. Food and Drug Administration (US)

Basic Information

fondaparinux sodium

11797-155

Regulatory Information

11797-155

ANDA208615

C73584

January 21, 2019

USA

These highlights do not include all the information needed to use FONDAPARINUX SODIUM INJECTION safely and effectively. See full prescribing information for FONDAPARINUX SODIUM INJECTION.FONDAPARINUX SODIUM injection, for subcutaneous use Initial U.S. Approval: 2001

HUMAN PRESCRIPTION DRUG LABEL

11

Company Information

Italfarmaco S.p.A

428179329

Active Ingredients

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

fondaparinux sodium

Quantity: 5 mg in 0.4 mL

Code: X0Q6N9USOZ

Class Code: ACTIB

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Active Moieties

FONDAPARINUX

Code: J177FOW5JL

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