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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022363
Company: KOWA CO

Products on NDA 022363

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022363

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

Labels for NDA 022363

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

Therapeutic Equivalents for NDA 022363

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	205961	AMNEAL PHARMS NY
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	205977	HETERO LABS LTD V
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	205961	AMNEAL PHARMS NY
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	205977	HETERO LABS LTD V
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	205961	AMNEAL PHARMS NY
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	205977	HETERO LABS LTD V
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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