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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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/03/2009 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022363s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022363s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022363s000TOC.cfm
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022363s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022363Orig1s022ltr.pdf
11/09/2022 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022363s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022363Orig1s020ltr.pdf
09/25/2020 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022363s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022363Orig1s018ltr.pdf
10/18/2019 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022363s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022363Orig1s017ltr.pdf
05/16/2019 SUPPL-15 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022363s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022363Orig1s015ltr.pdf
04/21/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
10/16/2013 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022363s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022363Orig1s012ltr.pdf
11/18/2016 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022363s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022363Orig1s011ltr.pdf
10/31/2012 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022363Orig1s010ltr.pdf
02/28/2012 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022363s008,s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022363s008s009.pdf
02/28/2012 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022363s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022363s008,s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022363s008s009.pdf
08/03/2011 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022363s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022363s006ltr.pdf
06/16/2011 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022363s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022363s005ltr.pdf
06/01/2010 SUPPL-2 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022363s002ltr.pdf

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

LIVALO

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIVALO PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription Yes AB 022363 KOWA CO
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 206015 AUROBINDO PHARMA
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 206029 LUPIN LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 206070 MYLAN
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 205932 ORIENT PHARMA CO LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 205955 SAWAI USA
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET;ORAL Prescription No AB 206047 ZYDUS PHARMS

TABLET;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIVALO PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription Yes AB 022363 KOWA CO
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 206015 AUROBINDO PHARMA
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 206029 LUPIN LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 206070 MYLAN
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 205932 ORIENT PHARMA CO LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 205955 SAWAI USA
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET;ORAL Prescription No AB 206047 ZYDUS PHARMS

TABLET;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIVALO PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription Yes AB 022363 KOWA CO
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 206015 AUROBINDO PHARMA
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 206029 LUPIN LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 206070 MYLAN
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 205932 ORIENT PHARMA CO LTD
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 205955 SAWAI USA
PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET;ORAL Prescription No AB 206047 ZYDUS PHARMS
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