Documents
Application Sponsors
ANDA 214501 | ZYDUS PHARMS USA | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
None (Tentative Approval) | 004 |
None (Tentative Approval) | 005 |
Application Products
001 | TABLET;ORAL | 10MG | 0 | BRIVARACETAM | BRIVARACETAM |
002 | TABLET;ORAL | 25MG | 0 | BRIVARACETAM | BRIVARACETAM |
003 | TABLET;ORAL | 50MG | 0 | BRIVARACETAM | BRIVARACETAM |
004 | TABLET;ORAL | 75MG | 0 | BRIVARACETAM | BRIVARACETAM |
005 | TABLET;ORAL | 100MG | 0 | BRIVARACETAM | BRIVARACETAM |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-06-11 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
CDER Filings
ZYDUS PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 214501
[companyName] => ZYDUS PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"BRIVARACETAM","activeIngredients":"BRIVARACETAM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/11\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-06-11
)
)