Application Sponsors
ANDA 213185 | GRANULES PHARMS | |
Marketing Status
Application Products
001 | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | 0 | TROSPIUM CHLORIDE | TROSPIUM CHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-04-23 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
GRANULES PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 213185
[companyName] => GRANULES PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"TROSPIUM CHLORIDE","activeIngredients":"TROSPIUM CHLORIDE","strength":"60MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-04-23
)
)