Application Sponsors
| NDA 018934 | YAOPHARMA CO LTD | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 250MG | 0 | METHYLDOPA | METHYLDOPA |
| 002 | TABLET;ORAL | 500MG | 0 | METHYLDOPA | METHYLDOPA |
FDA Submissions
| ORIG | 1 | AP | 1984-06-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1985-05-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1985-05-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1985-05-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1985-05-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1986-03-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1986-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1986-08-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1986-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1986-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1986-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1986-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1986-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1986-11-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1986-11-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1986-11-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1987-06-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1988-08-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1988-08-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1988-08-12 | |
| LABELING; Labeling | SUPPL | 36 | AP | 1989-09-06 | |
| LABELING; Labeling | SUPPL | 37 | AP | 1991-02-23 | |
| LABELING; Labeling | SUPPL | 38 | AP | 1993-02-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1995-03-27 | |
| LABELING; Labeling | SUPPL | 40 | AP | 1996-06-05 | |
| LABELING; Labeling | SUPPL | 41 | AP | 1998-04-28 | |
| LABELING; Labeling | SUPPL | 42 | AP | 1998-08-05 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 39 | Null | 0 |
CDER Filings
YAOPHARMA CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 18934
[companyName] => YAOPHARMA CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"METHYLDOPA","activeIngredients":"METHYLDOPA","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHYLDOPA","activeIngredients":"METHYLDOPA","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METHYLDOPA","submission":"METHYLDOPA","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METHYLDOPA","submission":"METHYLDOPA","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)