Application Sponsors
Marketing Status
Application Products
001 | SUSPENSION;ORAL | 300MG/5ML | 0 | OXCARBAZEPINE | OXCARBAZEPINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-07-09 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
AKORN
cder:Array
(
[0] => Array
(
[ApplNo] => 211420
[companyName] => AKORN
[docInserts] => ["",""]
[products] => [{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"300MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-07-09
)
)