Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
None (Tentative Approval) | 004 |
None (Tentative Approval) | 005 |
None (Tentative Approval) | 006 |
Application Products
001 | TABLET;ORAL | 0.25MG | 0 | BREXPIPRAZOLE | BREXPIPRAZOLE |
002 | TABLET;ORAL | 0.5MG | 0 | BREXPIPRAZOLE | BREXPIPRAZOLE |
003 | TABLET;ORAL | 1MG | 0 | BREXPIPRAZOLE | BREXPIPRAZOLE |
004 | TABLET;ORAL | 2MG | 0 | BREXPIPRAZOLE | BREXPIPRAZOLE |
005 | TABLET;ORAL | 3MG | 0 | BREXPIPRAZOLE | BREXPIPRAZOLE |
006 | TABLET;ORAL | 4MG | 0 | BREXPIPRAZOLE | BREXPIPRAZOLE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-08-29 | STANDARD |
Submissions Property Types
CDER Filings
ZENARA
cder:Array
(
[0] => Array
(
[ApplNo] => 213477
[companyName] => ZENARA
[docInserts] => ["",""]
[products] => [{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BREXPIPRAZOLE","activeIngredients":"BREXPIPRAZOLE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/29\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-08-29
)
)