Application Sponsors
ANDA 203025 | UNICHEM LABS LTD | |
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 | 2MG | 0 | ARIPIPRAZOLE | ARIPIPRAZOLE |
002 | TABLET;ORAL | 5MG | 0 | ARIPIPRAZOLE | ARIPIPRAZOLE |
003 | TABLET;ORAL | 10MG | 0 | ARIPIPRAZOLE | ARIPIPRAZOLE |
004 | TABLET;ORAL | 15MG | 0 | ARIPIPRAZOLE | ARIPIPRAZOLE |
005 | TABLET;ORAL | 20MG | 0 | ARIPIPRAZOLE | ARIPIPRAZOLE |
006 | TABLET;ORAL | 30MG | 0 | ARIPIPRAZOLE | ARIPIPRAZOLE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-06-29 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
006 | Prescription | AB |
CDER Filings
UNICHEM LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203025
[companyName] => UNICHEM LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/29\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-06-29
)
)