TREVENA INC FDA Approval NDA 210730

NDA 210730

TREVENA INC

FDA Drug Application

Application #210730

Documents

Letter2020-08-10
Label2020-08-10
Review2020-09-04

Application Sponsors

NDA 210730TREVENA INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS1.5MG0OLINVYKOLICERIDINE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-08-07STANDARD

Submissions Property Types

ORIG1Null2

CDER Filings

TREVENA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210730
            [companyName] => TREVENA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLINVYK","activeIngredients":"OLICERIDINE","strength":"1.5MG","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/07\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210730s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210730s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210730Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-08-07
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.