Application Sponsors
| ANDA 073262 | EPIC PHARMA LLC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 200MG | 0 | SULINDAC | SULINDAC |
| 002 | TABLET;ORAL | 150MG | 0 | SULINDAC | SULINDAC |
FDA Submissions
| ORIG | 1 | AP | 1991-09-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1993-12-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-07-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1994-07-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1995-02-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1997-06-23 | |
| LABELING; Labeling | SUPPL | 18 | AP | 2007-12-20 | |
| LABELING; Labeling | SUPPL | 20 | AP | 2009-06-24 | |
| LABELING; Labeling | SUPPL | 21 | AP | 2016-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2021-05-07 | STANDARD |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 22 | Null | 7 |
CDER Filings
EPIC PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 73262
[companyName] => EPIC PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"SULINDAC","activeIngredients":"SULINDAC","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SULINDAC","activeIngredients":"SULINDAC","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SULINDAC","submission":"SULINDAC","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SULINDAC","submission":"SULINDAC","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)