Application Sponsors
ANDA 204993 | HETERO LABS LTD III | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 200MG | 0 | RUFINAMIDE | RUFINAMIDE |
002 | TABLET;ORAL | 400MG | 0 | RUFINAMIDE | RUFINAMIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-05-11 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
HETERO LABS LTD III
cder:Array
(
[0] => Array
(
[ApplNo] => 204993
[companyName] => HETERO LABS LTD III
[docInserts] => ["",""]
[products] => [{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-05-11
)
)