Application Sponsors
| ANDA 074024 | AUROLIFE PHARMA LLC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | CAPSULE;ORAL | 50MG | 0 | KETOPROFEN | KETOPROFEN |
| 002 | CAPSULE;ORAL | 75MG | 0 | KETOPROFEN | KETOPROFEN |
FDA Submissions
| ORIG | 1 | AP | 1995-12-29 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1998-02-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-04-22 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-05-09 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 15 |
CDER Filings
AUROLIFE PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 74024
[companyName] => AUROLIFE PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"KETOPROFEN","activeIngredients":"KETOPROFEN","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KETOPROFEN","activeIngredients":"KETOPROFEN","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"KETOPROFEN","submission":"KETOPROFEN","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KETOPROFEN","submission":"KETOPROFEN","actionType":"75MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)