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FDA Approval

Warfarin Sodium

CompanyPhysicians Total Care, Inc. (DUNS: 194123980)

Effective Date

March 6, 2012

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Warfarin(4 mg in 1 1)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products (1)

Warfarin Sodium

NDC Product Code

54868-4402

Application Number

ANDA040663

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 9, 2012

Ingredients

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671PClass: IACT

Code: 6153CWM0CLClass: ACTIBQuantity: 4 mg in 1 1

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

STARCH, PREGELATINIZED CORNInactive

Code: O8232NY3SJClass: IACT

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