BLUEPRINT MEDICINES FDA Approval NDA 213721

NDA 213721

BLUEPRINT MEDICINES

FDA Drug Application

Application #213721

Documents

Label2020-09-08
Letter2020-09-08

Application Sponsors

NDA 213721BLUEPRINT MEDICINES

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL100MG2GAVRETOPRALSETINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntitySUPPL1AP2020-09-04PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

BLUEPRINT MEDICINES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213721
            [companyName] => BLUEPRINT MEDICINES
            [docInserts] => ["",""]
            [products] => [{"drugName":"GAVRETO","activeIngredients":"PRALSETINIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"09\/04\/2020","submission":"SUPPL-1","supplementCategories":"Type 1 - New Molecular Entity","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213721s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/04\/2020","submission":"SUPPL-1","actionType":"","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":""}]
            [supplements] => [{"actionDate":"09\/04\/2020","submission":"SUPPL-1","supplementCategories":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213721s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213721Orig1s000ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-09-04
        )

)

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