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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 202458

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NDA 202458 describes FLUVASTATIN SODIUM, which is a drug marketed by Mylan Pharms Inc, Teva Pharms, Beijing, Pharmobedient, and Teva Pharms Usa, and is included in five NDAs. It is available from four suppliers. Additional details are available on the FLUVASTATIN SODIUM profile page.

The generic ingredient in FLUVASTATIN SODIUM is fluvastatin sodium. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.

Summary for 202458

Tradename:	FLUVASTATIN SODIUM
Applicant:	Pharmobedient
Ingredient:	fluvastatin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 80MG BASE
Approval Date:	Sep 11, 2015	TE:		RLD:	No

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