Application 077491

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	80MG	No	No
002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	10MG	No	No
003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	20MG	No	No
004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	40MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5235	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Sandoz Inc	ANDA	Current
63629-7086	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-7086	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current