Application Sponsors
| ANDA 087565 | YAOPHARMA CO LTD | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 25MG | 0 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE |
FDA Submissions
| ORIG | 1 | AP | 1982-03-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1982-08-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1983-02-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1982-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1983-06-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1983-06-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1985-10-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1986-04-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1986-04-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1986-04-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1988-09-02 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1989-11-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1991-10-31 | |
| LABELING; Labeling | SUPPL | 19 | AP | 1992-08-11 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1994-03-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1994-01-24 | |
| LABELING; Labeling | SUPPL | 22 | AP | 1995-07-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1998-01-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1998-12-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1998-12-01 | |
| LABELING; Labeling | SUPPL | 26 | AP | 2020-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2020-08-20 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 15 |
| SUPPL | 27 | Null | 15 |
CDER Filings
YAOPHARMA CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 87565
[companyName] => YAOPHARMA CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)