MYLAN Application 202458

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUVASTATIN SODIUM	FLUVASTATIN SODIUM	TABLET, EXTENDED RELEASE;ORAL	EQ 80MG BASE	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5121	Fluvastatin Sodium	fluvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5121	Fluvastatin Sodium	fluvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current