Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021350
Company: SKYEPHARMA AG
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
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
05/15/2019 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

TRIGLIDE

There are no Therapeutic Equivalents.

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