Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021695
Company: LUPIN
Company: LUPIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANTARA (MICRONIZED) | FENOFIBRATE | 43MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| ANTARA (MICRONIZED) | FENOFIBRATE | 87MG | CAPSULE;ORAL | Discontinued | None | No | No |
| ANTARA (MICRONIZED) | FENOFIBRATE | 130MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| ANTARA (MICRONIZED) | FENOFIBRATE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| ANTARA (MICRONIZED) | FENOFIBRATE | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/01/2025 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021695s029lbl.pdf | |
| 07/30/2024 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021695s028lbl.pdf | |
| 06/03/2021 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021695s022lbl.pdf | |
| 05/15/2019 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021695s020lbl.pdf | |
| 02/04/2019 | SUPPL-18 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021695s018lbl.pdf | |
| 11/07/2018 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021695s019lbl.pdf | |
| 05/18/2018 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021695s017lbl.pdf | |
| 09/11/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021695s016lbl.pdf | |
| 08/31/2015 | SUPPL-12 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021695s012lbl.pdf |
| 10/18/2013 | SUPPL-9 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021695s009lbl.pdf |
| 12/19/2012 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021695s010lbl.pdf | |
| 03/01/2012 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021695s008lbl.pdf | |
| 06/03/2008 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021695s006lbl.pdf | |
| 11/30/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021695lbl.pdf |