Details for New Drug Application (NDA): 009218
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The generic ingredient in COUMADIN 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 009218
Tradename: | COUMADIN |
Applicant: | Bristol Myers Squibb |
Ingredient: | warfarin sodium |
Patents: | 0 |
Profile for product number 005
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Profile for product number 007
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Profile for product number 012
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 75MG/VIAL | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
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