Application 202887

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	25MG	No	No
002	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	50MG	No	No
003	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No
004	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52817-240	Lamotrigine Extended Release	lamotrigine extended release	TruPharma, LLC	ANDA	Current
52817-240	Lamotrigine Extended Release	lamotrigine extended release	TruPharma, LLC	ANDA	Current
52817-240	Lamotrigine Extended Release	lamotrigine extended release	TruPharma, LLC	ANDA	Current
52817-241	Lamotrigine Extended Release	lamotrigine extended release	TruPharma, LLC	ANDA	Current
52817-241	Lamotrigine Extended Release	lamotrigine extended release	TruPharma, LLC	ANDA	Current
52817-241	Lamotrigine Extended Release	lamotrigine extended release	TruPharma, LLC	ANDA	Current
52817-242	Lamotrigine Extended Release	lamotrigine extended release	TruPharma, LLC	ANDA	Current
52817-242	Lamotrigine Extended Release	lamotrigine extended release	TruPharma, LLC	ANDA	Current
52817-242	Lamotrigine Extended Release	lamotrigine extended release	TruPharma, LLC	ANDA	Current
52817-243	Lamotrigine Extended Release	lamotrigine extended release	TruPharma, LLC	ANDA	Current
52817-243	Lamotrigine Extended Release	lamotrigine extended release	TruPharma, LLC	ANDA	Current
52817-243	Lamotrigine Extended Release	lamotrigine extended release	TruPharma, LLC	ANDA	Current