MedPath
FDA Approval

Warfarin Sodium

June 22, 2017

HUMAN PRESCRIPTION DRUG LABEL

Warfarin(7.5 mg in 1 1)

Manufacturing Establishments (1)

Aphena Pharma Solutions - Tennessee, LLC

Aphena Pharma Solutions - Tennessee, LLC

128385585

Products (8)

Warfarin Sodium

43353-053

ANDA090935

ANDA (C73584)

ORAL

April 25, 2015

MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
WarfarinActive
Code: 6153CWM0CLClass: ACTIBQuantity: 7.5 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RTClass: IACT

Warfarin Sodium

43353-023

ANDA090935

ANDA (C73584)

ORAL

April 25, 2015

WarfarinActive
Code: 6153CWM0CLClass: ACTIBQuantity: 5 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RTClass: IACT

Warfarin Sodium

43353-054

ANDA090935

ANDA (C73584)

ORAL

April 25, 2015

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
WarfarinActive
Code: 6153CWM0CLClass: ACTIBQuantity: 10 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT

Warfarin Sodium

43353-030

ANDA090935

ANDA (C73584)

ORAL

April 25, 2015

HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RTClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
WarfarinActive
Code: 6153CWM0CLClass: ACTIBQuantity: 3 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT

Warfarin Sodium

43353-033

ANDA090935

ANDA (C73584)

ORAL

April 25, 2015

HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
WarfarinActive
Code: 6153CWM0CLClass: ACTIBQuantity: 4 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT

Warfarin Sodium

43353-028

ANDA090935

ANDA (C73584)

ORAL

April 25, 2015

WarfarinActive
Code: 6153CWM0CLClass: ACTIBQuantity: 1 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RTClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT

Warfarin Sodium

43353-029

ANDA090935

ANDA (C73584)

ORAL

April 25, 2015

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
WarfarinActive
Code: 6153CWM0CLClass: ACTIBQuantity: 2.5 mg in 1 1
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RTClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Warfarin Sodium

43353-021

ANDA090935

ANDA (C73584)

ORAL

April 25, 2015

WarfarinActive
Code: 6153CWM0CLClass: ACTIBQuantity: 2 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RTClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
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