Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE, EXTENDED RELEASE;ORAL | 5MG | 0 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE |
002 | CAPSULE, EXTENDED RELEASE;ORAL | 10MG | 0 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE |
003 | CAPSULE, EXTENDED RELEASE;ORAL | 15MG | 0 | DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-06-27 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
NESHER PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 209111
[companyName] => NESHER PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"5MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"10MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"15MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-06-27
)
)