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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022418
Company: ATHENA

Summary Review

Products on NDA 022418

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022418

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

Labels for NDA 022418

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

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