Application Sponsors
ANDA 208826 | BIONPHARMA INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 12.5MG | 0 | TETRABENAZINE | TETRABENAZINE |
002 | TABLET;ORAL | 25MG | 0 | TETRABENAZINE | TETRABENAZINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-12-18 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
BIONPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208826
[companyName] => BIONPHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"TETRABENAZINE","activeIngredients":"TETRABENAZINE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TETRABENAZINE","activeIngredients":"TETRABENAZINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/18\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-12-18
)
)