Application Sponsors
ANDA 205064 | HETERO LABS LTD V | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Prescription | 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 | AP | 2015-04-28 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2020-05-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2020-05-28 | UNKNOWN |
LABELING; Labeling | SUPPL | 6 | AP | 2020-05-28 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2020-05-28 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 3 | Null | 7 |
SUPPL | 4 | Null | 15 |
SUPPL | 6 | Null | 15 |
SUPPL | 7 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
006 | Prescription | AB |
CDER Filings
HETERO LABS LTD V
cder:Array
(
[0] => Array
(
[ApplNo] => 205064
[companyName] => HETERO LABS LTD V
[docInserts] => ["",""]
[products] => [{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARIPIPRAZOLE","activeIngredients":"ARIPIPRAZOLE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/28\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/28\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/28\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/28\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/28\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/28\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-05-28
)
)