Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022224
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRILIPIX CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription AB Yes No
TRILIPIX CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/15/2008 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022224s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022224s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022224_trilipix_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022224s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/28/2019 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022224s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021203Orig1s009, 021656Orig1s029, 022224Orig1s015ltr.pdf
11/07/2018 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022224s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022224Orig1s014ltr.pdf
05/18/2018 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022224s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022224Orig1s013ltr.pdf
11/18/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/27/2015 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022224Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022224Orig1s011ltr.pdf
04/17/2015 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/28/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/05/2012 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022224Orig1s008ltr.pdf
09/05/2012 SUPPL-7 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022224Orig1s008ltr.pdf
09/30/2011 SUPPL-6 REMS-Modified, REMS-Assessment Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022224s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022224s005,s006ltr.pdf
09/30/2011 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022224s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022224s005,s006ltr.pdf
03/14/2011 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022224s004ltr.pdf
09/14/2010 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022224s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022224s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/28/2019 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022224s015lbl.pdf
11/07/2018 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022224s014lbl.pdf
05/18/2018 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022224s013lbl.pdf
04/27/2015 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022224Orig1s011lbl.pdf
09/05/2012 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008lbl.pdf
09/05/2012 SUPPL-7 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008lbl.pdf
09/30/2011 SUPPL-6 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022224s005s006lbl.pdf
09/30/2011 SUPPL-6 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022224s005s006lbl.pdf
09/30/2011 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022224s005s006lbl.pdf
09/14/2010 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022224s003lbl.pdf
12/15/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022224s000lbl.pdf

TRILIPIX

CAPSULE, DELAYED RELEASE;ORAL; EQ 45MG FENOFIBRIC ACID
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 200920 ACTAVIS ELIZABETH
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 208705 ALEMBIC PHARMS LTD
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 201573 ANCHEN PHARMS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 212598 AUROBINDO PHARMA LTD
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 211626 GRAVITI PHARMS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 200264 IMPAX LABS INC
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 200750 LUPIN LTD
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 210469 TWI PHARMS
TRILIPIX CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription Yes AB 022224 ABBVIE

CAPSULE, DELAYED RELEASE;ORAL; EQ 135MG FENOFIBRIC ACID
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 200920 ACTAVIS ELIZABETH
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 208705 ALEMBIC PHARMS LTD
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 201573 ANCHEN PHARMS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 212598 AUROBINDO PHARMA LTD
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 211626 GRAVITI PHARMS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 200264 IMPAX LABS INC
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 200750 LUPIN LTD
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 210469 TWI PHARMS
TRILIPIX CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription Yes AB 022224 ABBVIE

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