Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE, DELAYED RELEASE;ORAL | EQ 45MG FENOFIBRIC ACID | 1 | TRILIPIX | CHOLINE FENOFIBRATE |
| 002 | CAPSULE, DELAYED RELEASE;ORAL | EQ 135MG FENOFIBRIC ACID | 1 | TRILIPIX | CHOLINE FENOFIBRATE |
FDA Submissions
| TYPE 2; Type 2 - New Active Ingredient | ORIG | 1 | AP | 2008-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2010-09-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 4 | AP | 2011-03-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 5 | AP | 2011-09-30 | 901 REQUIRED |
| REMS; REMS | SUPPL | 6 | AP | 2011-09-30 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2012-09-05 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2012-09-05 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2013-01-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2015-04-17 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2015-04-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2015-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2018-05-18 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 14 | AP | 2018-11-07 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2019-03-28 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2021-06-03 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2021-06-03 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 6 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
ABBVIE
cder:Array
(
[0] => Array
(
[ApplNo] => 22224
[companyName] => ABBVIE
[docInserts] => ["",""]
[products] => [{"drugName":"TRILIPIX","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 45MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TRILIPIX","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 135MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"03\/28\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022224s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022224s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022224s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2015","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022224Orig1s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/05\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022224s007s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/05\/2012","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022224s007s008lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"09\/30\/2011","submission":"SUPPL-6","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022224s005s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2011","submission":"SUPPL-6","supplementCategories":"REMS-Assessment","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022224s005s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022224s005s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2010","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022224s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022224s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TRILIPIX","submission":"CHOLINE FENOFIBRATE","actionType":"EQ 45MG FENOFIBRIC ACID","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TRILIPIX","submission":"CHOLINE FENOFIBRATE","actionType":"EQ 135MG FENOFIBRIC ACID","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-03-28
)
)