Application Sponsors
ANDA 214961 | ELITE LABS INC | |
Marketing Status
Application Products
001 | FOR SOLUTION;ORAL | 500MG/PACKET | 0 | VIGABATRIN | VIGABATRIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-06-24 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ELITE LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 214961
[companyName] => ELITE LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"VIGABATRIN","submission":"VIGABATRIN","actionType":"500MG\/PACKET","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)