NDA 021656

ABBVIE

FDA Drug Application

Application #021656

Documents

• Letter: 2007-09-25
• Letter: 2008-04-16
• Letter: 2010-10-25
• Label: 2004-11-08
• Label: 2010-10-21
• Label: 2011-09-23
• Label: 2013-02-06
• Letter: 2004-11-08
• Letter: 2011-09-26
• Letter: 2013-02-07
• Label: 2011-09-23
• Review: 2006-04-21
• Letter: 2018-05-21
• Label: 2018-05-22
• Label: 2018-11-08
• Letter: 2018-11-16
• Letter: 2019-03-29
• Label: 2019-06-07
• Letter: 2021-06-07
• Letter: 2021-06-07
• Label: 2021-06-10

Application Sponsors

NDA 021656

ABBVIE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	48MG	1	TRICOR	FENOFIBRATE
002	TABLET;ORAL	145MG	1	TRICOR	FENOFIBRATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2004-11-05	STANDARD
LABELING; Labeling	SUPPL	4	AP	2007-09-10	STANDARD
LABELING; Labeling	SUPPL	11	AP	2007-09-10	STANDARD
LABELING; Labeling	SUPPL	13	AP	2008-04-15	STANDARD
LABELING; Labeling	SUPPL	19	AP	2010-10-20	UNKNOWN
LABELING; Labeling	SUPPL	20	AP	2011-09-22	UNKNOWN
LABELING; Labeling	SUPPL	23	AP	2013-02-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2014-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	26	AP	2018-05-18	901 REQUIRED
LABELING; Labeling	SUPPL	27	AP	2018-11-06	STANDARD
LABELING; Labeling	SUPPL	29	AP	2019-03-28	STANDARD
LABELING; Labeling	SUPPL	30	AP	2011-09-20	STANDARD
LABELING; Labeling	SUPPL	31	AP	2021-06-03	901 REQUIRED

Submissions Property Types

SUPPL	19	Null	6
SUPPL	20	Null	6
SUPPL	23	Null	6
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	15
SUPPL	27	Null	6
SUPPL	29	Null	15
SUPPL	30	Null	0
SUPPL	31	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21656
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRICOR","activeIngredients":"FENOFIBRATE","strength":"48MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TRICOR","activeIngredients":"FENOFIBRATE","strength":"145MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/28\/2019","submission":"SUPPL-29","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021656s029lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2018","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021656s027lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021656s026,021203s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2013","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021656s023lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2011","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021656s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2011","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021656s030lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2010","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021656s019lbl.pdf\"}]","notes":""},{"actionDate":"11\/05\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21656lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRICOR","submission":"FENOFIBRATE","actionType":"48MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TRICOR","submission":"FENOFIBRATE","actionType":"145MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-03-28
        )

)