Application Sponsors
ANDA 072552 | YAOPHARMA CO LTD | |
Marketing Status
Application Products
001 | TABLET;ORAL | 20MG | 0 | TIMOLOL MALEATE | TIMOLOL MALEATE |
FDA Submissions
| ORIG | 1 | AP | 1989-04-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1993-07-27 | |
LABELING; Labeling | SUPPL | 3 | AP | 1993-08-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1995-04-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-11-18 | |
LABELING; Labeling | SUPPL | 6 | AP | 1997-10-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1999-05-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-12-13 | |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
CDER Filings
YAOPHARMA CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 72552
[companyName] => YAOPHARMA CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TIMOLOL MALEATE","submission":"TIMOLOL MALEATE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)