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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206029
Company: LUPIN LTD

Products on ANDA 206029

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 206029

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/20/2023	SUPPL-3			Label is not available on this site.
11/20/2023	SUPPL-2			Label is not available on this site.
11/20/2023	SUPPL-1			Label is not available on this site.

Therapeutic Equivalents for ANDA 206029

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	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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