Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-03-29 | STANDARD |
Submissions Property Types
CDER Filings
MICRO LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 214880
[companyName] => MICRO LABS
[docInserts] => ["",""]
[products] => [{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"50MG\/5ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/29\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-03-29
)
)