AVADEL CNS PHARMA LLC FDA Approval NDA 214755

NDA 214755

AVADEL CNS PHARMA LLC

FDA Drug Application

Application #214755

Documents

Letter2022-07-25

Application Sponsors

NDA 214755AVADEL CNS PHARMA LLC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004

FDA Submissions

UNKNOWN; ORIG1TA2022-07-18STANDARD

Submissions Property Types

ORIG1Orphan5

CDER Filings

AVADEL CNS PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214755
            [companyName] => AVADEL CNS PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUMRYZ","activeIngredients":"SODIUM OXYBATE","strength":"4.5G","dosageForm":"SUSPENSION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LUMRYZ","activeIngredients":"SODIUM OXYBATE","strength":"6G","dosageForm":"SUSPENSION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LUMRYZ","activeIngredients":"SODIUM OXYBATE","strength":"7.5G","dosageForm":"SUSPENSION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LUMRYZ","activeIngredients":"SODIUM OXYBATE","strength":"9G","dosageForm":"SUSPENSION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/18\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214755Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-18
        )

)

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