Application Sponsors
ANDA 212919 | BIONPHARMA INC | |
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 | 2019-11-22 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2022-02-25 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
CDER Filings
BIONPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212919
[companyName] => BIONPHARMA INC
[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":"11\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-11-22
)
)