Application Sponsors
ANDA 202579 | MYLAN PHARMS INC | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | CAPSULE;ORAL | 43MG | 0 | FENOFIBRATE (MICRONIZED) | FENOFIBRATE |
002 | CAPSULE;ORAL | 130MG | 0 | FENOFIBRATE (MICRONIZED) | FENOFIBRATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2013-01-10 | |
LABELING; Labeling | SUPPL | 7 | AP | 2022-01-04 | STANDARD |
Submissions Property Types
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202579
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"43MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"130MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/10\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2013-01-10
)
)