Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022363
Company: KOWA CO
Company: KOWA CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIVALO | PITAVASTATIN CALCIUM | EQ 1MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| LIVALO | PITAVASTATIN CALCIUM | EQ 2MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| LIVALO | PITAVASTATIN CALCIUM | EQ 4MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/14/2024 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022363s022lbl.pdf | |
| 11/09/2022 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022363s020lbl.pdf | |
| 09/25/2020 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022363s018lbl.pdf | |
| 10/18/2019 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022363s017lbl.pdf | |
| 05/16/2019 | SUPPL-15 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022363s015lbl.pdf | |
| 11/18/2016 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022363s011lbl.pdf | |
| 10/16/2013 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022363s012lbl.pdf | |
| 10/31/2012 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s010lbl.pdf | |
| 02/28/2012 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s008s009lbl.pdf | |
| 02/28/2012 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s008s009lbl.pdf | |
| 08/03/2011 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022363s006lbl.pdf | |
| 06/16/2011 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022363s005lbl.pdf | |
| 08/03/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022363s000lbl.pdf |