Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 20MG | 0 | TROSPIUM CHLORIDE | TROSPIUM CHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-02-16 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
AMICI
cder:Array
(
[0] => Array
(
[ApplNo] => 215781
[companyName] => AMICI
[docInserts] => ["",""]
[products] => [{"drugName":"TROSPIUM CHLORIDE","activeIngredients":"TROSPIUM CHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/16\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-02-16
)
)