Documents
Application Sponsors
| ANDA 200913 | MYLAN PHARMS INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | CAPSULE, DELAYED RELEASE;ORAL | EQ 45MG FENOFIBRIC ACID | 0 | FENOFIBRIC ACID | CHOLINE FENOFIBRATE |
| 002 | CAPSULE, DELAYED RELEASE;ORAL | EQ 135MG FENOFIBRIC ACID | 0 | FENOFIBRIC ACID | CHOLINE FENOFIBRATE |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2013-03-25 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2015-07-06 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-09-19 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-09-19 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-11-16 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 200913
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"FENOFIBRIC ACID","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 45MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FENOFIBRIC ACID","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 135MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/25\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200913Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/19\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/19\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/06\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-09-19
)
)