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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 209397

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NDA 209397 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 209397

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

Pharmacology for NDA: 209397

Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Suppliers and Packaging for NDA: 209397

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUVASTATIN SODIUM	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	209397	ANDA	Lannett Company, Inc.	0527-2580	0527-2580-32	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-32)
FLUVASTATIN SODIUM	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	209397	ANDA	Lannett Company, Inc.	0527-2580	0527-2580-37	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-37)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 80MG BASE
Approval Date:	Apr 26, 2021	TE:	AB	RLD:	No

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