Documents
Application Sponsors
ANDA 075270 | ACTAVIS LABS FL INC | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Application Products
001 | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | 0 | KETOPROFEN | KETOPROFEN |
002 | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | 0 | KETOPROFEN | KETOPROFEN |
003 | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | 0 | KETOPROFEN | KETOPROFEN |
FDA Submissions
| ORIG | 1 | AP | 1999-03-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2002-09-20 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2002-12-24 | |
LABELING; Labeling | SUPPL | 7 | AP | 2006-07-03 | |
LABELING; Labeling | SUPPL | 8 | AP | 2006-09-22 | |
LABELING; Labeling | SUPPL | 10 | AP | 2008-02-21 | |
LABELING; Labeling | SUPPL | 13 | AP | 2016-05-09 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 13 | Null | 15 |
SUPPL | 14 | Null | 7 |
CDER Filings
ACTAVIS LABS FL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 75270
[companyName] => ACTAVIS LABS FL INC
[docInserts] => ["",""]
[products] => [{"drugName":"KETOPROFEN","activeIngredients":"KETOPROFEN","strength":"200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KETOPROFEN","activeIngredients":"KETOPROFEN","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KETOPROFEN","activeIngredients":"KETOPROFEN","strength":"150MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"KETOPROFEN","submission":"KETOPROFEN","actionType":"200MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KETOPROFEN","submission":"KETOPROFEN","actionType":"100MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KETOPROFEN","submission":"KETOPROFEN","actionType":"150MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)