Documents
Application Sponsors
NDA 215310 | TAKEDA PHARMS USA | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 40MG | 0 | EXKIVITY | MOBOCERTINIB |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2021-09-15 | PRIORITY |
Submissions Property Types
CDER Filings
TAKEDA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 215310
[companyName] => TAKEDA PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"EXKIVITY","activeIngredients":"MOBOCERTINIB","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"09\/15\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215310s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/15\/2021","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\\\/2021\\\/215310s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215310Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-09-15
)
)