Application Sponsors
| ANDA 071894 | WATSON LABS TEVA | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG | 0 | ACETOHEXAMIDE | ACETOHEXAMIDE |
FDA Submissions
| ORIG | 1 | AP | 1987-11-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1991-05-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1991-01-28 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1991-09-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-10-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1997-11-25 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 71894
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"ACETOHEXAMIDE","activeIngredients":"ACETOHEXAMIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ACETOHEXAMIDE","submission":"ACETOHEXAMIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)