Application 090607

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Related Records

Company: ALEMBIC PHARMS LTD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAMOTRIGINE	LAMOTRIGINE	TABLET;ORAL	25MG	No	No
002	LAMOTRIGINE	LAMOTRIGINE	TABLET;ORAL	100MG	No	No
003	LAMOTRIGINE	LAMOTRIGINE	TABLET;ORAL	150MG	No	No
004	LAMOTRIGINE	LAMOTRIGINE	TABLET;ORAL	200MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-274	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-274	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-275	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-275	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-276	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-276	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-277	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
46708-277	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Limited	ANDA	Current
50090-2992	Lamotrigine	Lamotrigine	A-S Medication Solutions	ANDA	Current
55154-8129	Lamotrigine	Lamotrigine	Cardinal Health	ANDA	Current
62332-037	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-037	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-037	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-037	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-037	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-037	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-038	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-038	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-038	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-038	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-038	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-038	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-039	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-039	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-039	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-039	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-039	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-039	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-040	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-040	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-040	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-040	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-040	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-040	Lamotrigine	Lamotrigine	Alembic Pharmaceuticals Inc.	ANDA	Current
63739-516	Lamotrigine	Lamotrigine	McKesson Corporation	ANDA	Current
63739-516	Lamotrigine	Lamotrigine	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-517	Lamotrigine	Lamotrigine	McKesson Corporation	ANDA	Current
63739-517	Lamotrigine	Lamotrigine	McKesson Corporation dba SKY Packaging	ANDA	Current

Documents

Document	Submission type	Date
9280	ORIG	2012-02-14