Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021612
Company: CIPHER PHARMS INC
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 |
---|---|---|---|---|---|
06/03/2021 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021612s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021612Orig1s024ltr.pdf | |
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 |
---|---|---|---|---|---|
06/03/2021 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021612s024lbl.pdf | |
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 |