Details for New Drug Application (NDA): 040616
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NDA 040616 describes WARFARIN SODIUM, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Usa, Barr, Chartwell Rx, Invagen Pharms, Ipca Labs Ltd, Pliva, Taro, Usl Pharma, Watson Labs, and Zydus Pharms Usa, and is included in seventeen NDAs. It is available from twenty-three suppliers. Additional details are available on the WARFARIN SODIUM profile page.
The generic ingredient in WARFARIN SODIUM is warfarin sodium. There are twenty-two drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the warfarin sodium profile page.
The generic ingredient in WARFARIN SODIUM is warfarin sodium. There are twenty-two drug master file entries for this compound. Twenty-four 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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