Application Sponsors
| ANDA 072993 | YAOPHARMA CO LTD | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 2MG | 0 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1992-08-28 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1996-07-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-09-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1997-08-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1999-05-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-07-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-07-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2001-11-06 | |
| LABELING; Labeling | SUPPL | 13 | AP | 2016-11-03 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 13 | Null | 15 |
CDER Filings
YAOPHARMA CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 72993
[companyName] => YAOPHARMA CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LOPERAMIDE HYDROCHLORIDE","activeIngredients":"LOPERAMIDE HYDROCHLORIDE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LOPERAMIDE HYDROCHLORIDE","submission":"LOPERAMIDE HYDROCHLORIDE","actionType":"2MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)