Application Sponsors
ANDA 213550 | BEXIMCO PHARMS USA | |
Marketing Status
Application Products
001 | TABLET;ORAL | 5MG | 0 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-07-14 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
BEXIMCO PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 213550
[companyName] => BEXIMCO PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"OXYBUTYNIN CHLORIDE","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/14\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-07-14
)
)