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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022118
Company: SALIX

Products on NDA 022118

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FENOGLIDE	FENOFIBRATE	40MG	TABLET;ORAL	Prescription	AB	Yes	No
FENOGLIDE	FENOFIBRATE	120MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022118

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/10/2007	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022118lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022118s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022118_fenofibrate_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022118s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022118Orig1s013ltr.pdf
05/15/2019	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022118s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022118Orig1s010ltr.pdf
03/13/2019	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022118s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022118Orig1s009ltr.pdf
05/18/2018	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022118s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022118Orig1s007ltr.pdf
10/31/2012	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022118s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022118Orig1s005ltr.pdf
03/05/2012	SUPPL-3	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022118s003ltr.pdf
02/29/2008	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022118s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022118s001ltr.pdf

Labels for NDA 022118

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022118s013lbl.pdf
05/15/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022118s010lbl.pdf
03/13/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022118s009lbl.pdf
05/18/2018	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022118s007lbl.pdf
10/31/2012	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022118s005lbl.pdf
02/29/2008	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022118s001lbl.pdf
08/10/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022118lbl.pdf

Therapeutic Equivalents for NDA 022118

FENOGLIDE

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOFIBRATE	FENOFIBRATE	40MG	TABLET;ORAL	Prescription	No	AB	217732	CREEKWOOD PHARMS
FENOFIBRATE	FENOFIBRATE	40MG	TABLET;ORAL	Prescription	No	AB	204475	MYLAN PHARMS INC
FENOGLIDE	FENOFIBRATE	40MG	TABLET;ORAL	Prescription	Yes	AB	022118	SALIX

TABLET;ORAL; 120MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOFIBRATE	FENOFIBRATE	120MG	TABLET;ORAL	Prescription	No	AB	217732	CREEKWOOD PHARMS
FENOFIBRATE	FENOFIBRATE	120MG	TABLET;ORAL	Prescription	No	AB	204475	MYLAN PHARMS INC
FENOGLIDE	FENOFIBRATE	120MG	TABLET;ORAL	Prescription	Yes	AB	022118	SALIX

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