NDA 216059

LOXO ONCOLOGY INC

FDA Drug Application

Application #216059

Application Sponsors

NDA 216059

LOXO ONCOLOGY INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

JAYPIRCA

PIRTOBRUTINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2023-01-27

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

LOXO ONCOLOGY INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216059
            [companyName] => LOXO ONCOLOGY INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"JAYPIRCA","activeIngredients":"PIRTOBRUTINIB","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"JAYPIRCA","activeIngredients":"PIRTOBRUTINIB","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/27\/2023","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/216059Orig1s000Corrected_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/27\/2023","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\\\/2023\\\/216059Orig1s000Corrected_lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2023-01-27
        )

)