Details for New Drug Application (NDA): 040616
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NDA 040616 describes WARFARIN SODIUM, which is a drug marketed by Aiping Pharm Inc, Amneal Pharms, Aurobindo Pharma Usa, Barr, Chartwell Rx, Invagen Pharms, Pliva, Taro, Usl Pharma, Watson Labs, and Zydus Pharms Usa, and is included in seventeen NDAs. It is available from eighteen suppliers. Additional details are available on the WARFARIN SODIUM profile page.
The generic ingredient in WARFARIN SODIUM is warfarin sodium. There is one drug master file entry for this compound. Nineteen 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 is one drug master file entry for this compound. Nineteen 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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