TAKEDA PHARMS USA FDA Approval NDA 215310

NDA 215310

TAKEDA PHARMS USA

FDA Drug Application

Application #215310

Documents

Label2021-09-15
Letter2021-09-17
Review2021-10-14

Application Sponsors

NDA 215310TAKEDA PHARMS USA

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL40MG0EXKIVITYMOBOCERTINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-09-15PRIORITY

Submissions Property Types

ORIG1Null7

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
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.