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FDA Approval

Warfarin Sodium

CompanyA-S Medication Solutions (DUNS: 830016429)

Effective Date

February 4, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Warfarin(5 mg in 1 1)

Manufacturing Establishments (1)

A-S Medication Solutions

Labeler

A-S Medication Solutions

DUNS Number

830016429

Products (1)

Warfarin Sodium

NDC Product Code

50090-5058

Application Number

ANDA202202

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 30, 2022

Ingredients

Code: 6153CWM0CLClass: ACTIBQuantity: 5 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYDROXYPROPYL CELLULOSE (70000 WAMW)Inactive

Code: 66O7AQV0RTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

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