ZOGENIX INC FDA Approval NDA 212102

NDA 212102

ZOGENIX INC

FDA Drug Application

Application #212102

Documents

Letter2020-06-26
Label2020-06-26
Medication Guide2020-06-29

Application Sponsors

NDA 212102ZOGENIX INC

Marketing Status

Prescription001

Application Products

001SOLUTION; ORAL2.5MG/ML0FINTEPLAFENFLUAMINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2020-06-25PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

ZOGENIX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212102
            [companyName] => ZOGENIX INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/212102s000lbl.pdf#page=23"]
            [products] => [{"drugName":"FINTEPLA","activeIngredients":"FENFLURAMINE HYDROCHLORIDE","strength":"EQ 2.2MG BASE\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/25\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212102s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212102s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212102Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-06-25
        )

)

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