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 | Yes | No |
| LIPOFEN | FENOFIBRATE | 150MG | CAPSULE;ORAL | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/06/2025 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021612s026lbl.pdf | |
| 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 |