Application Sponsors
| ANDA 202893 | AUROLIFE PHARMA LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 5MG | 0 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE |
| 002 | TABLET;ORAL | 10MG | 0 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2013-07-31 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2017-01-04 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2022-02-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 1 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 4 | Null | 15 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
AUROLIFE PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 202893
[companyName] => AUROLIFE PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/31\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"01\/04\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2017-01-04
)
)