NDA 213400

EPIZYME INC

FDA Drug Application

Application #213400

Documents

• Label: 2020-06-18
• Medication Guide: 2020-06-18
• Letter: 2020-06-19
• Review: 2020-11-30

Application Sponsors

NDA 213400

EPIZYME INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

2

TAZVERIK

TAZEMETOSTAT HYDROBROMIDE

FDA Submissions

TYPE 9; Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval

ORIG

1

AP

2020-06-18

PRIORITY

Submissions Property Types

ORIG

1

Null

2

TE Codes

001

Prescription

TBD

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
        )

)