Details for New Drug Application (NDA): 214024
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The generic ingredient in TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE is tipiracil hydrochloride; trifluridine. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tipiracil hydrochloride; trifluridine profile page.
Summary for 214024
| Tradename: | TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE |
| Applicant: | Msn |
| Ingredient: | tipiracil hydrochloride; trifluridine |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 6.14MG BASE;15MG | ||||
| Approval Date: | Jan 8, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 8.19MG BASE;20MG | ||||
| Approval Date: | Jan 8, 2025 | TE: | AB | RLD: | No | ||||
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