Details for New Drug Application (NDA): 214008
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NDA 214008 describes TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE, which is a drug marketed by Natco and is included in one NDA. Additional details are available on the TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE profile page.
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.
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 214008
| Tradename: | TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE |
| Applicant: | Natco |
| 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: | Jun 13, 2023 | 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: | Jun 13, 2023 | TE: | AB | RLD: | No | ||||
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