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FDA Product

Warfarin Sodium

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

Basic Information

Warfarin Sodium

70934-589

Regulatory Information

70934-589

ANDA090935

C73584

April 28, 2020

USA

These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS. WARFARIN SODIUM tablets, for oral use Initial U.S. Approval: 1954

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

WARFARIN SODIUM

Quantity: 5 mg in 1 1

Code: 6153CWM0CL

Class Code: ACTIB

Active Moieties

WARFARIN

Code: 5Q7ZVV76EI

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