Application Sponsors
ANDA 202284 | ANI PHARMS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 400MG | 0 | FELBAMATE | FELBAMATE |
002 | TABLET;ORAL | 600MG | 0 | FELBAMATE | FELBAMATE |
FDA Submissions
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202284
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"FELBAMATE","activeIngredients":"FELBAMATE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FELBAMATE","activeIngredients":"FELBAMATE","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/04\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2015-11-04
)
)