Application Sponsors
| ANDA 085628 | AUROLIFE PHARMA LLC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG | 0 | SULFISOXAZOLE | SULFISOXAZOLE |
FDA Submissions
| ORIG | 1 | AP | 1977-06-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1982-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1982-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1982-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1982-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1982-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1982-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 1982-04-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1982-07-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1982-07-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 1982-07-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1983-08-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 1984-12-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 1984-12-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 1984-12-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 1995-08-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 2000-01-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 2001-05-09 | |
Submissions Property Types
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 60 | Null | 0 |
| SUPPL | 61 | Null | 0 |
CDER Filings
AUROLIFE PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 85628
[companyName] => AUROLIFE PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"SULFISOXAZOLE","activeIngredients":"SULFISOXAZOLE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SULFISOXAZOLE","submission":"SULFISOXAZOLE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)