Application Sponsors
ANDA 208227 | STRIDES PHARMA | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 0.5MG | 0 | DUTASTERIDE | DUTASTERIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-06-22 | STANDARD |
Submissions Property Types
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 208227
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"DUTASTERIDE","activeIngredients":"DUTASTERIDE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/22\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-06-22
)
)