Application Sponsors
| ANDA 071633 | YAOPHARMA CO LTD | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 100MG | 0 | TOLAZAMIDE | TOLAZAMIDE |
FDA Submissions
| ORIG | 1 | AP | 1987-12-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1990-04-05 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1992-07-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-10-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-10-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1996-04-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2001-01-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-05-09 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
CDER Filings
YAOPHARMA CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 71633
[companyName] => YAOPHARMA CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"TOLAZAMIDE","activeIngredients":"TOLAZAMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TOLAZAMIDE","submission":"TOLAZAMIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)