Application Sponsors
ANDA 208625 | BIONPHARMA INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | 0.125MG | 0 | DOFETILIDE | DOFETILIDE |
002 | CAPSULE;ORAL | 0.25MG | 0 | DOFETILIDE | DOFETILIDE |
003 | CAPSULE;ORAL | 0.5MG | 0 | DOFETILIDE | DOFETILIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-04-10 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2022-11-28 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
BIONPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208625
[companyName] => BIONPHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"DOFETILIDE","activeIngredients":"DOFETILIDE","strength":"0.125MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOFETILIDE","activeIngredients":"DOFETILIDE","strength":"0.25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOFETILIDE","activeIngredients":"DOFETILIDE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/10\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-04-10
)
)