Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022118
Company: SALIX
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 204475 MYLAN
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 204475 MYLAN
FENOGLIDE FENOFIBRATE 120MG TABLET;ORAL Prescription Yes AB 022118 SALIX

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