Application Sponsors
| ANDA 087093 | ANI PHARMS INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG | 0 | TOLBUTAMIDE | TOLBUTAMIDE |
FDA Submissions
| ORIG | 1 | AP | 1980-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1982-04-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1987-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1987-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1987-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1987-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1987-11-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1987-11-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1987-11-03 | |
| LABELING; Labeling | SUPPL | 31 | AP | 1991-10-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1992-10-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1993-04-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1997-05-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1998-10-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1998-10-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1998-12-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1999-08-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1999-11-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2000-01-28 | |
Submissions Property Types
| SUPPL | 19 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 87093
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"TOLBUTAMIDE","activeIngredients":"TOLBUTAMIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TOLBUTAMIDE","submission":"TOLBUTAMIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)