NDA 211964

SUPERNUS PHARMS

FDA Drug Application

Application #211964

Documents

• Label: 2021-04-02
• Medication Guide: 2021-04-02
• Letter: 2021-04-06
• Review: 2021-05-03
• Letter: 2021-04-05
• Review: 2021-05-03
• Label: 2022-05-02
• Medication Guide: 2022-05-02
• Letter: 2022-05-03

Application Sponsors

NDA 211964

SUPERNUS PHARMS

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	100MG	2	QELBREE	VILOXAZINE HYDROCHLORIDE
002	CAPSULE, EXTENDED RELEASE;ORAL	150MG	2	QELBREE	VILOXAZINE HYDROCHLORIDE
003	CAPSULE, EXTENDED RELEASE;ORAL	200MG	2	QELBREE	VILOXAZINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-04-02	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	6

TE Codes

001	Prescription	TBD
002	Prescription	TBD
003	Prescription	TBD

CDER Filings

SUPERNUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211964
            [companyName] => SUPERNUS PHARMS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/211964s000lbl.pdf#page=18"]
            [products] => [{"drugName":"QELBREE","activeIngredients":"VILOXAZINE HYDROCHLORIDE","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"QELBREE","activeIngredients":"VILOXAZINE HYDROCHLORIDE","strength":"150MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"QELBREE","activeIngredients":"VILOXAZINE HYDROCHLORIDE","strength":"200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"04\/02\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211964s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/02\/2021","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\\\/2021\\\/211964s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211964Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-04-02
        )

)