Application 078526

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	250MG	No	No
002	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	500MG	No	No
003	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	750MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42043-190	Levetiracetam	Levetiracetam	Karalex Pharma LLC	ANDA	Current
42043-191	Levetiracetam	Levetiracetam	Karalex Pharma LLC	ANDA	Current
42043-192	Levetiracetam	Levetiracetam	Karalex Pharma LLC	ANDA	Current
42254-056	Levetiracetam	Levetiracetam	Rebel Distributors Corp	ANDA	Current