Application Sponsors
| ANDA 086881 | YAOPHARMA CO LTD | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 25MG;25MG | 0 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; SPIRONOLACTONE |
FDA Submissions
| ORIG | 1 | AP | 1980-07-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1982-05-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1982-05-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1982-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1982-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1983-01-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1983-01-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1983-01-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1983-08-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1983-08-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1985-10-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1984-04-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1984-04-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1984-06-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1986-07-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1986-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1986-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1986-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1989-03-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1989-03-31 | |
| LABELING; Labeling | SUPPL | 36 | AP | 1990-12-27 | |
| LABELING; Labeling | SUPPL | 37 | AP | 1990-05-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1994-06-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1996-02-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1997-10-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1998-12-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1998-12-01 | |
| LABELING; Labeling | SUPPL | 43 | AP | 1998-06-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2001-05-09 | |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 44 | Null | 0 |
CDER Filings
YAOPHARMA CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 86881
[companyName] => YAOPHARMA CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; SPIRONOLACTONE","strength":"25MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; SPIRONOLACTONE","actionType":"25MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)