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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 090595

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NDA 090595 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 090595

Tradename:	FLUVASTATIN SODIUM
Applicant:	Mylan Pharms Inc
Ingredient:	fluvastatin sodium
Patents:	0

Pharmacology for NDA: 090595

Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Suppliers and Packaging for NDA: 090595

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUVASTATIN SODIUM	fluvastatin sodium	CAPSULE;ORAL	090595	ANDA	Mylan Pharmaceuticals Inc.	0378-8020	0378-8020-77	90 CAPSULE in 1 BOTTLE, PLASTIC (0378-8020-77)
FLUVASTATIN SODIUM	fluvastatin sodium	CAPSULE;ORAL	090595	ANDA	Mylan Pharmaceuticals Inc.	0378-8020	0378-8020-93	30 CAPSULE in 1 BOTTLE, PLASTIC (0378-8020-93)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Apr 11, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 40MG BASE
Approval Date:	Apr 11, 2012	TE:	AB	RLD:	No

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