Documents
Application Sponsors
Marketing Status
| Over-the-counter | 001 |
| Over-the-counter | 002 |
Application Products
| 001 | CAPSULE;ORAL | 1MG | 1 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE |
| 002 | CAPSULE;ORAL | 2MG | 1 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2005-08-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2015-12-11 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2017-03-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2019-01-31 | N/A |
| LABELING; Labeling | SUPPL | 14 | AP | 2020-06-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 14 | Null | 15 |
CDER Filings
BIONPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21855
[companyName] => BIONPHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"LOPERAMIDE HYDROCHLORIDE","activeIngredients":"LOPERAMIDE HYDROCHLORIDE","strength":"1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"},{"drugName":"LOPERAMIDE HYDROCHLORIDE","activeIngredients":"LOPERAMIDE HYDROCHLORIDE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"01\/31\/2019","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021855Orig1s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021855Orig1s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021855lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"LOPERAMIDE HYDROCHLORIDE","submission":"LOPERAMIDE HYDROCHLORIDE","actionType":"1MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"LOPERAMIDE HYDROCHLORIDE","submission":"LOPERAMIDE HYDROCHLORIDE","actionType":"2MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-01-31
)
)