Details for New Drug Application (NDA): 090935
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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-four suppliers are listed for this compound. Additional details are available on the warfarin sodium profile page.
Summary for 090935
Tradename: | WARFARIN SODIUM |
Applicant: | Invagen Pharms |
Ingredient: | warfarin sodium |
Patents: | 0 |
Pharmacology for NDA: 090935
Mechanism of Action | Vitamin K Inhibitors |
Suppliers and Packaging for NDA: 090935
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
WARFARIN SODIUM | warfarin sodium | TABLET;ORAL | 090935 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-021 | 43353-021-30 | 30 TABLET in 1 BOTTLE (43353-021-30) |
WARFARIN SODIUM | warfarin sodium | TABLET;ORAL | 090935 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-021 | 43353-021-35 | 35 TABLET in 1 BOTTLE (43353-021-35) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | May 25, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | May 25, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | May 25, 2011 | TE: | AB | RLD: | No |
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