Application Sponsors
Marketing Status
Application Products
001 | FOR SOLUTION;ORAL | 500MG/PACKET | 0 | VIGABATRIN | VIGABATRIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-01-26 | STANDARD |
REMS; REMS | SUPPL | 2 | AP | 2022-10-12 | |
Submissions Property Types
TE Codes
CDER Filings
ANNORA PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 213519
[companyName] => ANNORA PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-01-26
)
)