Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021612
Company: CIPHER PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIPOFEN FENOFIBRATE 50MG CAPSULE;ORAL Prescription None Yes No
LIPOFEN FENOFIBRATE 100MG CAPSULE;ORAL Discontinued None No No
LIPOFEN FENOFIBRATE 150MG CAPSULE;ORAL Prescription None 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
01/11/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021612lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/21612s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021612_lipofen_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/15/2019 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021612s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021612Orig1s020ltr.pdf
05/18/2018 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021612s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021612Orig1s018ltr.pdf
11/06/2018 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021612s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021612Orig1s017ltr.pdf
12/23/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/18/2013 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021612s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021612Orig1s014,s015ltr.pdf
01/18/2013 SUPPL-14 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021612s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021612Orig1s014,s015ltr.pdf
01/18/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/31/2011 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021612s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021612s007ltr.pdf
12/12/2008 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021612s002, s004ltr.pdf
12/12/2008 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021612s002, s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/15/2019 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021612s020lbl.pdf
11/06/2018 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021612s017lbl.pdf
05/18/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021612s018lbl.pdf
01/18/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021612s014s015lbl.pdf
01/18/2013 SUPPL-14 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021612s014s015lbl.pdf
10/31/2011 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021612s007lbl.pdf
01/11/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021612lbl.pdf

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