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FDA Product

Enoxaparin sodium

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

Basic Information

Enoxaparin sodium

0955-1016

Regulatory Information

0955-1016

NDA020164

C73605

December 7, 2023

USA

These highlights do not include all the information needed to use ENOXAPARIN SODIUM injection safely and effectively. See full prescribing information for ENOXAPARIN SODIUM injection. ENOXAPARIN SODIUM injection, for subcutaneous and intravenous use Initial U.S. Approval: 1993

HUMAN PRESCRIPTION DRUG LABEL

17

Company Information

Winthrop U.S, a business of sanofi-aventis U.S. LLC

824676584

Active Ingredients

BENZYL ALCOHOL

Quantity: 45 mg in 3 mL

Code: LKG8494WBH

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

ENOXAPARIN SODIUM

Quantity: 300 mg in 3 mL

Code: 8NZ41MIK1O

Class Code: ACTIB

Active Moieties

ENOXAPARIN

Code: E47C0NF7LV

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