An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206047
Company: ZYDUS PHARMS

Products on ANDA 206047

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 206047

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/2023	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
06/11/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206047

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

Top