Application Sponsors
ANDA 215579 | BIONPHARMA INC | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 2MG | 0 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-10-22 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
BIONPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 215579
[companyName] => BIONPHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"LOPERAMIDE HYDROCHLORIDE","activeIngredients":"LOPERAMIDE HYDROCHLORIDE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-10-22
)
)