Application Sponsors
ANDA 210920 | BIONPHARMA INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET, FOR SUSPENSION;ORAL | 125MG | 0 | DEFERASIROX | DEFERASIROX |
002 | TABLET, FOR SUSPENSION;ORAL | 250MG | 0 | DEFERASIROX | DEFERASIROX |
003 | TABLET, FOR SUSPENSION;ORAL | 500MG | 0 | DEFERASIROX | DEFERASIROX |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-11-20 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
BIONPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 210920
[companyName] => BIONPHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"125MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"250MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"500MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-11-20
)
)