Application 201791

Type: ANDA
Sponsor: PAR PHARM

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
49884-561	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-561	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-561	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-562	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-562	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-562	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-563	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-563	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-563	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-564	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-564	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-564	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-604	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-604	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-604	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-605	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-605	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
49884-605	Lamotrigine Extended Release	lamotrigine extended release	Par Pharmaceutical, Inc.	ANDA	Current
63629-7020	Lamotrigine Extended Release	lamotrigine extended release	Bryant Ranch Prepack	ANDA	Current
63629-7020	Lamotrigine Extended Release	lamotrigine extended release	Bryant Ranch Prepack	ANDA	Current
63629-7020	Lamotrigine Extended Release	lamotrigine extended release	Bryant Ranch Prepack	ANDA	Current
70518-0489	Lamotrigine Extended Release	lamotrigine extended release	REMEDYREPACK INC.	ANDA	Current
70518-0489	Lamotrigine Extended Release	lamotrigine extended release	REMEDYREPACK INC.	ANDA	Current

Application 201791

Related Records#

Application Products#

NDC Listings For This Application#