Application 207497

Type: ANDA
Sponsor: AMNEAL PHARMS

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
005	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	250MG	No	No
006	LAMOTRIGINE	LAMOTRIGINE	TABLET, EXTENDED RELEASE;ORAL	300MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-443	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-443	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-444	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-444	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-445	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-445	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-446	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-446	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-447	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-447	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-448	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
42291-448	Lamotrigine	Lamotrigine	AvKARE	ANDA	Current
65162-949	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-949	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-949	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-949	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-949	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-949	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-956	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-956	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-956	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-956	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-956	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-956	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-958	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-958	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-958	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-958	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-958	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-958	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-986	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-986	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-986	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-986	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-986	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-986	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-988	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-988	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-988	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-988	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-988	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-988	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-990	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-990	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-990	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-990	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-990	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-990	Lamotrigine	Lamotrigine	Amneal Pharmaceuticals LLC	ANDA	Current
70518-3187	Lamotrigine	Lamotrigine	REMEDYREPACK INC.	ANDA	Current

Application 207497

Related Records#

Application Products#

NDC Listings For This Application#