Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021656
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRICOR FENOFIBRATE 48MG TABLET;ORAL Prescription AB Yes No
TRICOR FENOFIBRATE 145MG TABLET;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
11/05/2004 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21656lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21656ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021656s000_TricorTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/20/2011 SUPPL-30 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021656s030lbl.pdf
03/28/2019 SUPPL-29 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021656s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021203Orig1s009, 021656Orig1s029, 022224Orig1s015ltr.pdf
11/06/2018 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021656s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021203Orig1s008,021656Orig1s027ltr.pdf
05/18/2018 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021656s026,021203s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021203Orig1s007,021656Orig1s026ltr.pdf
04/17/2015 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/25/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/05/2013 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021656s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021656Orig1s023ltr.pdf
09/22/2011 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021656s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021656s020ltr.pdf
10/20/2010 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021656s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021656s019ltr.pdf
04/15/2008 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021249s019,021656s013ltr.pdf
09/10/2007 SUPPL-11 Labeling

Label is not available on this site.

09/10/2007 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021656s004,s011ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/28/2019 SUPPL-29 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021656s029lbl.pdf
11/06/2018 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021656s027lbl.pdf
05/18/2018 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021656s026,021203s007lbl.pdf
02/05/2013 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021656s023lbl.pdf
09/22/2011 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021656s020lbl.pdf
09/20/2011 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021656s030lbl.pdf
10/20/2010 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021656s019lbl.pdf
11/05/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21656lbl.pdf

TRICOR

TABLET;ORAL; 48MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 210476 ALEMBIC PHARMS LTD
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 209951 AMNEAL PHARMS LLC
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 205118 AUROBINDO PHARMA LTD
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 208709 CIPLA
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 204598 HETERO LABS LTD III
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 090856 LUPIN LTD
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 202856 MYLAN PHARMS INC
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 211080 PRINSTON INC
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 200884 SUN PHARM
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 090715 VALEANT PHARMS NORTH
TRICOR FENOFIBRATE 48MG TABLET;ORAL Prescription Yes AB 021656 ABBVIE

TABLET;ORAL; 145MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 210476 ALEMBIC PHARMS LTD
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 209951 AMNEAL PHARMS LLC
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 205118 AUROBINDO PHARMA LTD
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 208709 CIPLA
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 204598 HETERO LABS LTD III
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 090856 LUPIN LTD
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 202856 MYLAN PHARMS INC
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 211080 PRINSTON INC
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 200884 SUN PHARM
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 090715 VALEANT PHARMS NORTH
TRICOR FENOFIBRATE 145MG TABLET;ORAL Prescription Yes AB 021656 ABBVIE

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English