Documents
Application Sponsors
| NDA 211810 | DAIICHI SANKYO INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | EQ 200MG BASE | 1 | TURALIO | PEXIDARTINIB HYDROCHLORIDE |
| 002 | CAPSULE;ORAL | EQ 125MG BASE | 1 | TURALIO | PEXIDARTINIB HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2019-08-02 | PRIORITY |
| REMS; REMS | SUPPL | 2 | AP | 2019-11-19 | N/A |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-04-17 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-04-10 | STANDARD |
| REMS; REMS | SUPPL | 5 | AP | 2020-08-04 | N/A |
| REMS; REMS | SUPPL | 6 | AP | 2020-12-16 | N/A |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-10-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2022-10-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2022-10-14 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2022-07-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 7 |
CDER Filings
DAIICHI SANKYO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 211810
[companyName] => DAIICHI SANKYO INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/211810s003lbl.pdf#page=21"]
[products] => [{"drugName":"TURALIO","activeIngredients":"PEXIDARTINIB HYDROCHLORIDE","strength":"EQ 200MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"04\/17\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211810s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211810s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211810s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/02\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211810s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211810Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211810Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"08\/04\/2020","submission":"SUPPL-5","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211810Orig1s005ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/10\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211810s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211810Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"11\/19\/2019","submission":"SUPPL-2","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211810Orig1s001,s002ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"11\/19\/2019","submission":"SUPPL-1","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211810Orig1s001,s002ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-08-04
)
)