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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021350
Company: SKYEPHARMA AG

Products on NDA 021350

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIGLIDE	FENOFIBRATE	50MG	TABLET;ORAL	Discontinued	None	No	No
TRIGLIDE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	BX	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021350

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/07/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021350lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021350ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021350s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/14/2024	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021350s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021350Orig1s024ltr.pdf
06/03/2021	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021350s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021350Orig1s023ltr.pdf
05/15/2019	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021350s022lbl.pdf
05/18/2018	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021350s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021350Orig1s020ltr.pdf
11/13/2015	SUPPL-15	Labeling-Patient Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021350Orig1s015ltr.pdf
04/15/2015	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021350s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021350Orig1s014ltr.pdf
01/15/2013	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021350s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021350Orig1s013ltr.pdf
04/19/2012	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021350s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021350s010ltr.pdf
11/17/2008	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021350s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021350s008ltr.pdf
01/15/2008	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021350s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021350s005ltr.pdf
07/03/2006	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021350s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021350s002LTR.pdf

Labels for NDA 021350

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/14/2024	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021350s024lbl.pdf
06/03/2021	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021350s023lbl.pdf
05/15/2019	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021350s022lbl.pdf
05/18/2018	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021350s020lbl.pdf
04/15/2015	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021350s014lbl.pdf
01/15/2013	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021350s013lbl.pdf
04/19/2012	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021350s010lbl.pdf
11/17/2008	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021350s008lbl.pdf
01/15/2008	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021350s005lbl.pdf
07/03/2006	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021350s002lbl.pdf
05/07/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021350lbl.pdf

Therapeutic Equivalents for NDA 021350

TRIGLIDE

There are no Therapeutic Equivalents.

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