Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | TRICOR | FENOFIBRATE |
| 003 | TABLET;ORAL | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | TRICOR | FENOFIBRATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2001-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2014-12-05 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2017-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2018-05-18 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 8 | AP | 2018-11-06 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-03-28 | STANDARD |
Submissions Property Types
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 7 |
CDER Filings
ABBVIE INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21203
[companyName] => ABBVIE INC
[docInserts] => ["",""]
[products] => [{"drugName":"TRICOR","activeIngredients":"FENOFIBRATE","strength":"54MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TRICOR","activeIngredients":"FENOFIBRATE","strength":"160MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/28\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021203s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021203s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2018","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021656s026,021203s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021203s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/05\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021203s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21203lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TRICOR","submission":"FENOFIBRATE","actionType":"54MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"TRICOR","submission":"FENOFIBRATE","actionType":"160MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-03-28
)
)