Details for New Drug Application (NDA): 040616
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The generic ingredient in WARFARIN SODIUM is warfarin sodium. There are twenty-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the warfarin sodium profile page.
Summary for 040616
Tradename: | WARFARIN SODIUM |
Applicant: | Pliva |
Ingredient: | warfarin sodium |
Patents: | 0 |
Pharmacology for NDA: 040616
Mechanism of Action | Vitamin K Inhibitors |
Suppliers and Packaging for NDA: 040616
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
WARFARIN SODIUM | warfarin sodium | TABLET;ORAL | 040616 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1712 | 0093-1712-01 | 100 TABLET in 1 BOTTLE (0093-1712-01) |
WARFARIN SODIUM | warfarin sodium | TABLET;ORAL | 040616 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1712 | 0093-1712-10 | 1000 TABLET in 1 BOTTLE (0093-1712-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Jul 5, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Jul 5, 2006 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
Approval Date: | Jul 5, 2006 | TE: | AB | RLD: | No |
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