Application Sponsors
ANDA 209041 | SCIECURE PHARMA INC | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 3MG | 0 | BUDESONIDE | BUDESONIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-09-28 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
SCIECURE PHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 209041
[companyName] => SCIECURE PHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"3MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-09-28
)
)