Application Sponsors
| ANDA 207240 | SCIEGEN PHARMS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | 0 | ARIPIPRAZOLE | ARIPIPRAZOLE |
| 002 | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | 0 | ARIPIPRAZOLE | ARIPIPRAZOLE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-04-18 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-02-05 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-02-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
SCIEGEN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 207240
[companyName] => SCIEGEN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"15MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/18\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/01\/2021","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/05\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2021-02-01
)
)