Details for New Drug Application (NDA): 040416
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The generic ingredient in JANTOVEN 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 040416
Tradename: | JANTOVEN |
Applicant: | Upsher Smith Labs |
Ingredient: | warfarin sodium |
Patents: | 0 |
Pharmacology for NDA: 040416
Mechanism of Action | Vitamin K Inhibitors |
Suppliers and Packaging for NDA: 040416
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
JANTOVEN | warfarin sodium | TABLET;ORAL | 040416 | ANDA | Upsher-Smith Laboratories, LLC | 0832-1211 | 0832-1211-00 | 100 TABLET in 1 BOTTLE (0832-1211-00) |
JANTOVEN | warfarin sodium | TABLET;ORAL | 040416 | ANDA | Upsher-Smith Laboratories, LLC | 0832-1211 | 0832-1211-01 | 100 BLISTER PACK in 1 CARTON (0832-1211-01) / 1 TABLET in 1 BLISTER PACK (0832-1211-89) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Oct 2, 2003 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Oct 2, 2003 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Oct 2, 2003 | TE: | AB | RLD: | No |
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