Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022418
Company: ATHENA
Company: ATHENA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FIBRICOR | FENOFIBRIC ACID | 35MG | TABLET;ORAL | Discontinued | None | Yes | No |
FIBRICOR | FENOFIBRIC ACID | 105MG | 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 |
---|---|---|---|---|---|---|---|
08/14/2009 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022418lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022418s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022418_fibricor_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022418s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/03/2021 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022418s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022418Orig1s019ltr.pdf | |
09/30/2019 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022418s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022418Orig1s016ltr.pdf | |
05/15/2019 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022418s015lbl.pdf | |
05/18/2018 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022418s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022418Orig1s014ltr.pdf | |
11/27/2015 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/06/2014 | SUPPL-11 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022418s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022418Orig1s011ltr.pdf | |
03/11/2013 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022418s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022418Orig1s010ltr.pdf | |
12/12/2012 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418Orig1s008,s009ltr.pdf | |
12/12/2012 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418Orig1s008,s009ltr.pdf | |
03/15/2012 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418s007ltr.pdf | |
01/03/2012 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022418s006ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/03/2021 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022418s019lbl.pdf | |
09/30/2019 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022418s016lbl.pdf | |
05/15/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022418s015lbl.pdf | |
05/18/2018 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022418s014lbl.pdf | |
01/06/2014 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022418s011lbl.pdf | |
03/11/2013 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022418s010lbl.pdf | |
12/12/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s008s009lbl.pdf | |
12/12/2012 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s008s009lbl.pdf | |
03/15/2012 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s007lbl.pdf | |
01/03/2012 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022418s006lbl.pdf | |
08/14/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022418lbl.pdf |