Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | TABLET;ORAL | 7MG | 0 | TERIFLUNOMIDE | TERIFLUNOMIDE |
002 | TABLET;ORAL | 14MG | 0 | TERIFLUNOMIDE | TERIFLUNOMIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-02-28 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2021-03-29 | STANDARD |
Submissions Property Types
CDER Filings
MYLAN
cder:Array
(
[0] => Array
(
[ApplNo] => 209702
[companyName] => MYLAN
[docInserts] => ["",""]
[products] => [{"drugName":"TERIFLUNOMIDE","activeIngredients":"TERIFLUNOMIDE","strength":"7MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TERIFLUNOMIDE","activeIngredients":"TERIFLUNOMIDE","strength":"14MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/22\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-06-22
)
)