NDA 210730

TREVENA INC

FDA Drug Application

Application #210730

Documents

• Letter: 2020-08-10
• Label: 2020-08-10
• Review: 2020-09-04
• Label: 2021-03-05
• Letter: 2021-03-05
• Federal Register Notice: 2021-10-08

Application Sponsors

NDA 210730

TREVENA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INTRAVENOUS	1.5MG	0	OLINVYK	OLICERIDINE
002	SOLUTION;INTRAVENOUS	2MG/2ML (1MG/ML)	1	OLINVYK	OLICERIDINE
003	SOLUTION;INTRAVENOUS	30MG/30ML (1MG/ML)	1	OLINVYK	OLICERIDINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-08-07

STANDARD

Submissions Property Types

ORIG

1

Null

2

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
        )

)