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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206015
Company: AUROBINDO PHARMA

Products on ANDA 206015

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET;ORAL	Prescription	AB	No	No
PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET;ORAL	Prescription	AB	No	No
PITAVASTATIN CALCIUM	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206015

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206015Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206015Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/11/2024	SUPPL-8	Labeling, Labeling-Package Insert		Label is not available on this site.
06/02/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/02/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/24/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/24/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 206015

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206015Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 206015

PITAVASTATIN CALCIUM

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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