BLUEPRINT MEDICINES FDA Approval NDA 214701

NDA 214701

BLUEPRINT MEDICINES

FDA Drug Application

Application #214701

Documents

Label2020-12-01
Letter2020-12-02

Application Sponsors

NDA 214701BLUEPRINT MEDICINES

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL100MG2GAVRETOPRALSETINIB

FDA Submissions

TYPE 9; Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after ApprovalORIG1AP2020-12-01PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

BLUEPRINT MEDICINES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214701
            [companyName] => BLUEPRINT MEDICINES
            [docInserts] => ["",""]
            [products] => [{"drugName":"GAVRETO","activeIngredients":"PRALSETINIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/01\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214701s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214701s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-12-01
        )

)

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