Application Sponsors
| ANDA 070183 | YAOPHARMA CO LTD | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 25MG;250MG | 0 | METHYLDOPA AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METHYLDOPA |
FDA Submissions
| ORIG | 1 | AP | 1986-01-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1986-12-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1986-12-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1986-12-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1986-12-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1986-12-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1988-01-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1988-02-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1988-02-17 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1989-09-15 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1992-01-31 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1993-04-30 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1993-08-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1994-01-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1996-08-19 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1996-04-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1998-11-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1998-11-25 | |
| LABELING; Labeling | SUPPL | 28 | AP | 2020-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2020-08-20 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 28 | Null | 15 |
| SUPPL | 29 | Null | 15 |
CDER Filings
YAOPHARMA CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 70183
[companyName] => YAOPHARMA CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"METHYLDOPA AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; METHYLDOPA","strength":"25MG;250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METHYLDOPA AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; METHYLDOPA","actionType":"25MG;250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)