Application Sponsors
ANDA 213484 | BIONPHARMA INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 2MG;125MG | 0 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-09-10 | STANDARD |
Submissions Property Types
CDER Filings
BIONPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 213484
[companyName] => BIONPHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE","activeIngredients":"LOPERAMIDE HYDROCHLORIDE; SIMETHICONE","strength":"2MG;125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-09-10
)
)