Documents
Application Sponsors
| NDA 206316 | DAIICHI SANKYO INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | EQ 15MG BASE | 1 | SAVAYSA | EDOXABAN TOSYLATE |
| 002 | TABLET;ORAL | EQ 30MG BASE | 1 | SAVAYSA | EDOXABAN TOSYLATE |
| 003 | TABLET;ORAL | EQ 60MG BASE | 1 | SAVAYSA | EDOXABAN TOSYLATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2015-01-08 | STANDARD |
| EFFICACY; Efficacy | ORIG | 2 | AP | 2015-01-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2015-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-09-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2015-11-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2015-10-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2016-04-25 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2017-09-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2019-08-09 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2020-04-21 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2021-04-20 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2021-11-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| ORIG | 2 | Null | 7 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 15 |
| SUPPL | 18 | Null | 6 |
CDER Filings
DAIICHI SANKYO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 206316
[companyName] => DAIICHI SANKYO INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/206316s016lbl.pdf#page=35"]
[products] => [{"drugName":"SAVAYSA","activeIngredients":"EDOXABAN TOSYLATE","strength":"EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SAVAYSA","activeIngredients":"EDOXABAN TOSYLATE","strength":"EQ 30MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SAVAYSA","activeIngredients":"EDOXABAN TOSYLATE","strength":"EQ 60MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
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[originalApprovals] => [{"actionDate":"01\/08\/2015","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Efficacy","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/08\/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\\\/206316lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206316Orig2s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206316Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206316Orig1Orig2s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206316Orig1Orig2s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"04\/21\/2020","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206316s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/206316Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"08\/09\/2019","submission":"SUPPL-15","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206316s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206316Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"09\/29\/2017","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206316s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206316Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"04\/25\/2016","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/16\/2015","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/06\/2015","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/15\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206316s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206316Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"10\/30\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/10\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206316s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206316Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"08\/24\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-04-21
)
)