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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 206029

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NDA 206029 describes PITAVASTATIN CALCIUM, which is a drug marketed by Amneal Pharms Ny, Aurobindo Pharma, Hetero Labs Ltd V, Lupin Ltd, Mylan, Orient Pharma Co Ltd, Sawai Usa, and Zydus Pharms, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the PITAVASTATIN CALCIUM profile page.

The generic ingredient in PITAVASTATIN CALCIUM is pitavastatin calcium. There are fifteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the pitavastatin calcium profile page.

Summary for 206029

Tradename:	PITAVASTATIN CALCIUM
Applicant:	Lupin Ltd
Ingredient:	pitavastatin calcium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Nov 20, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE
Approval Date:	Nov 20, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	Nov 20, 2023	TE:	AB	RLD:	No

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