Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;ORAL | 1MG/ML | 0 | SIROLIMUS | SIROLIMUS |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-12-27 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
TORRENT
cder:Array
(
[0] => Array
(
[ApplNo] => 215016
[companyName] => TORRENT
[docInserts] => ["",""]
[products] => [{"drugName":"SIROLIMUS","activeIngredients":"SIROLIMUS","strength":"1MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/27\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-12-27
)
)