Details for New Drug Application (NDA): 009218
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NDA 009218 describes COUMADIN, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. Additional details are available on the COUMADIN profile page.
The generic ingredient in COUMADIN 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 COUMADIN 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 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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