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FDA Approval

Warfarin Sodium

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 31, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Warfarin(5 mg in 1 1)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Warfarin Sodium

Product Details

NDC Product Code
33261-357
Application Number
ANDA040301
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 31, 2014
WarfarinActive
Code: 6153CWM0CLClass: ACTIBQuantity: 5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
D&C RED NO. 6Inactive
Code: 481744AI4OClass: IACT
BARIUM OXIDEInactive
Code: 77603K202BClass: IACT

Warfarin Sodium

Product Details

NDC Product Code
33261-355
Application Number
ANDA040301
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 31, 2014
WarfarinActive
Code: 6153CWM0CLClass: ACTIBQuantity: 1 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
D&C RED NO. 6Inactive
Code: 481744AI4OClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
BARIUM OXIDEInactive
Code: 77603K202BClass: IACT

Warfarin Sodium

Product Details

NDC Product Code
33261-356
Application Number
ANDA040301
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 31, 2014
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
WarfarinActive
Code: 6153CWM0CLClass: ACTIBQuantity: 2 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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