SUPERNUS PHARMS FDA Approval NDA 211964

NDA 211964

SUPERNUS PHARMS

FDA Drug Application

Application #211964

Documents

Label2021-04-02
Medication Guide2021-04-02
Letter2021-04-06

Application Sponsors

NDA 211964SUPERNUS PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL100MG2QELBREEVILOXAZINE HYDROCHLORIDE
002CAPSULE, EXTENDED RELEASE;ORAL150MG2QELBREEVILOXAZINE HYDROCHLORIDE
003CAPSULE, EXTENDED RELEASE;ORAL200MG2QELBREEVILOXAZINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-04-02STANDARD

Submissions Property Types

ORIG1Null40

TE Codes

001PrescriptionTBD
002PrescriptionTBD
003PrescriptionTBD

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
        )

)

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