Application Sponsors
| ANDA 074100 | YAOPHARMA CO LTD | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | TABLET;ORAL | 200MG | 0 | CIMETIDINE | CIMETIDINE |
| 002 | TABLET;ORAL | 300MG | 0 | CIMETIDINE | CIMETIDINE |
| 003 | TABLET;ORAL | 400MG | 0 | CIMETIDINE | CIMETIDINE |
| 004 | TABLET;ORAL | 800MG | 0 | CIMETIDINE | CIMETIDINE |
FDA Submissions
| ORIG | 1 | AP | 1995-01-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1996-08-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-09-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1999-05-04 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1999-05-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1999-01-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-06-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-11-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2001-07-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2001-04-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2001-12-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-12-13 | |
| LABELING; Labeling | SUPPL | 14 | AP | 2001-12-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-12-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2001-05-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-04-19 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | 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 | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
CDER Filings
YAOPHARMA CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 74100
[companyName] => YAOPHARMA CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)