Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022363
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
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

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