Application Sponsors
| ANDA 090652 | EPIC PHARMA LLC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 5MG | 0 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE |
| 002 | TABLET;ORAL | 10MG | 0 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE |
FDA Submissions
| ORIG | 1 | AP | 2014-03-07 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2015-04-17 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2017-01-04 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-02-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
CDER Filings
EPIC PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 90652
[companyName] => EPIC PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DEXTROAMPHETAMINE SULFATE","submission":"DEXTROAMPHETAMINE SULFATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROAMPHETAMINE SULFATE","submission":"DEXTROAMPHETAMINE SULFATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)