Application Sponsors
ANDA 214922 | MSN LABS PVT LTD | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | SOLUTION; ORAL | 10MG/ML | 0 | BRIVARACETAM | BRIVARACETAM |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-06-07 | STANDARD |
Submissions Property Types
CDER Filings
MSN LABS PVT LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 214922
[companyName] => MSN LABS PVT LTD
[docInserts] => ["",""]
[products] => [{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"10MG\/ML","dosageForm":"SOLUTION; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/07\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-06-07
)
)