Details for New Drug Application (NDA): 078407

NDA 078407 describes FLUVASTATIN SODIUM, which is a drug marketed by Mylan Pharms Inc, Teva Pharms, Beijing, Norvium Bioscience, 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. Six suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.

Summary for 078407

Tradename:	FLUVASTATIN SODIUM
Applicant:	Teva Pharms
Ingredient:	fluvastatin sodium
Patents:	0

Pharmacology for NDA: 078407

Mechanism of Action

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Suppliers and Packaging for NDA: 078407

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUVASTATIN SODIUM	fluvastatin sodium	CAPSULE;ORAL	078407	ANDA	Teva Pharmaceuticals USA, Inc.	0093-7442	0093-7442-01	100 CAPSULE in 1 BOTTLE (0093-7442-01)
FLUVASTATIN SODIUM	fluvastatin sodium	CAPSULE;ORAL	078407	ANDA	Teva Pharmaceuticals USA, Inc.	0093-7442	0093-7442-56	30 CAPSULE in 1 BOTTLE (0093-7442-56)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jun 12, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 40MG BASE
Approval Date:	Jun 12, 2012	TE:	AB	RLD:	No

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