Application Sponsors
ANDA 203928 | STRIDES PHARMA | |
Marketing Status
Over-the-counter | 001 |
Over-the-counter | 002 |
Application Products
001 | FOR SOLUTION;ORAL | 17GM/SCOOPFUL | 0 | POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 |
002 | FOR SOLUTION;ORAL | 17GM/PACKET | 0 | POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-08-24 | |
Submissions Property Types
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 203928
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"POLYETHYLENE GLYCOL 3350","activeIngredients":"POLYETHYLENE GLYCOL 3350","strength":"17GM\/SCOOPFUL","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"POLYETHYLENE GLYCOL 3350","activeIngredients":"POLYETHYLENE GLYCOL 3350","strength":"17GM\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/24\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-08-24
)
)