EPIZYME INC FDA Approval NDA 213400

NDA 213400

EPIZYME INC

FDA Drug Application

Application #213400

Documents

Label2020-06-18
Medication Guide2020-06-18
Letter2020-06-19

Application Sponsors

NDA 213400EPIZYME INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL200MG2TAZVERIKTAZEMETOSTAT HYDROBROMIDE

FDA Submissions

TYPE 9; Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after ApprovalORIG1AP2020-06-18PRIORITY

Submissions Property Types

ORIG1Null2

TE Codes

001PrescriptionTBD

CDER Filings

EPIZYME INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213400
            [companyName] => EPIZYME INC
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/213400s000lbl.pdf#page=17"]
            [products] => [{"drugName":"TAZVERIK","activeIngredients":"TAZEMETOSTAT HYDROBROMIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"06\/18\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213400s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213400s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213400Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-06-18
        )

)

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