Details for New Drug Application (NDA): 022273
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The generic ingredient in OFORTA is fludarabine phosphate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.
Summary for 022273
| Tradename: | OFORTA |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | fludarabine phosphate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Dec 18, 2008 | TE: | RLD: | No | |||||
Expired US Patents for NDA 022273
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | OFORTA | fludarabine phosphate | TABLET;ORAL | 022273-001 | Dec 18, 2008 | 7,148,207 | ⤷ Start Trial |
| Sanofi Aventis Us | OFORTA | fludarabine phosphate | TABLET;ORAL | 022273-001 | Dec 18, 2008 | 7,547,776 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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