Documents
Application Sponsors
NDA 214755 | AVADEL CNS PHARMA LLC | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
None (Tentative Approval) | 004 |
Application Products
001 | SUSPENSION;ORAL | 4.5G | 0 | LUMRYZ | SODIUM OXYBATE |
002 | SUSPENSION;ORAL | 6G | 0 | LUMRYZ | SODIUM OXYBATE |
003 | SUSPENSION;ORAL | 7.5G | 0 | LUMRYZ | SODIUM OXYBATE |
004 | SUSPENSION;ORAL | 9G | 0 | LUMRYZ | SODIUM OXYBATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-07-18 | STANDARD |
Submissions Property Types
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
)
)