Application Sponsors
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 | 2015-11-23 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2017-02-01 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-02-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 15 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
AVANTHI INC
cder:Array
(
[0] => Array
(
[ApplNo] => 203548
[companyName] => AVANTHI INC
[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":"11\/23\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/01\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2017-02-01
)
)