Application Sponsors
ANDA 213763 | RICONPHARMA LLC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 5MG | 0 | AMPHETAMINE SULFATE | AMPHETAMINE SULFATE |
002 | TABLET;ORAL | 10MG | 0 | AMPHETAMINE SULFATE | AMPHETAMINE SULFATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-08-24 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
CDER Filings
RICONPHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 213763
[companyName] => RICONPHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMPHETAMINE SULFATE","submission":"AMPHETAMINE SULFATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMPHETAMINE SULFATE","submission":"AMPHETAMINE SULFATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)