Application Sponsors
| ANDA 085813 | AUROLIFE PHARMA LLC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 20MG | 0 | PREDNISONE | PREDNISONE |
FDA Submissions
| ORIG | 1 | AP | 1978-05-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1982-06-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1982-06-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1982-06-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1982-06-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1982-11-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1984-09-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1984-09-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1985-02-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1986-01-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1986-01-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1986-01-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1986-08-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1986-08-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1986-08-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1986-08-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1987-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1987-08-12 | |
| LABELING; Labeling | SUPPL | 28 | AP | 1989-08-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1991-02-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1995-04-10 | |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | 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 | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
CDER Filings
AUROLIFE PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 85813
[companyName] => AUROLIFE PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PREDNISONE","submission":"PREDNISONE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)