Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021656
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRICOR | FENOFIBRATE | 48MG | TABLET;ORAL | Discontinued | None | Yes | No |
TRICOR | FENOFIBRATE | 145MG | TABLET;ORAL | Discontinued | None | Yes | No |
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 |
---|---|---|---|---|---|
06/03/2021 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021656s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022224Orig1s016, s017; 021656Orig1s030, s031ltr.pdf | |
06/03/2021 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021656s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022224Orig1s016, s017; 021656Orig1s030, s031ltr.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 |
---|---|---|---|---|---|
06/03/2021 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021656s030s031lbl.pdf | |
06/03/2021 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021656s030s031lbl.pdf | |
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 | |
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 |