ABBVIE INC FDA Approval NDA 215206

NDA 215206

ABBVIE INC

FDA Drug Application

Application #215206

Documents

Letter2021-09-29
Label2021-09-29

Application Sponsors

NDA 215206ABBVIE INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL10MG2QULIPTAATOGEPANT
002TABLET;ORAL30MG2QULIPTAATOGEPANT
003TABLET;ORAL60MG2QULIPTAATOGEPANT

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-09-28PRIORITY

Submissions Property Types

ORIG1Null40

TE Codes

001PrescriptionTBD
002PrescriptionTBD
003PrescriptionTBD

CDER Filings

ABBVIE INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215206
            [companyName] => ABBVIE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"QULIPTA","activeIngredients":"ATOGEPANT","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"QULIPTA","activeIngredients":"ATOGEPANT","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"QULIPTA","activeIngredients":"ATOGEPANT","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"09\/28\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215206Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215206Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215206Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-09-28
        )

)

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