Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 6.14MG BASE;15MG | 1 | LONSURF | TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE |
| 002 | TABLET;ORAL | EQ 8.19MG BASE;20MG | 1 | LONSURF | TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2015-09-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2015-11-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2016-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2017-03-30 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2017-06-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2019-02-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2020-01-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 15 |
CDER Filings
TAIHO ONCOLOGY
cder:Array
(
[0] => Array
(
[ApplNo] => 207981
[companyName] => TAIHO ONCOLOGY
[docInserts] => ["",""]
[products] => [{"drugName":"LONSURF","activeIngredients":"TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","strength":"EQ 6.14MG BASE;15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"LONSURF","activeIngredients":"TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","strength":"EQ 8.19MG BASE;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"01\/01\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207981s009lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2019","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207981s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207981s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207981s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207981s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/22\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207981s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207981Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207981Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207981Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"01\/01\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207981s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207981Orig1s009ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2021\\\/207981Orig1s009.pdf\"}]","notes":">"},{"actionDate":"02\/22\/2019","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207981s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207981Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"06\/29\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207981s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207981Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"03\/30\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207981s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207981Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"04\/05\/2016","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/20\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/13\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-01-01
)
)