Application 207763

Type: ANDA
Sponsor: ZYDUS 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
68382-979	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-979	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-979	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-979	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-980	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-980	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-980	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-980	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-981	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-981	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-981	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-981	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-982	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-982	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-982	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-982	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-983	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-983	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-983	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-983	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-984	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-984	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-984	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-984	Lamotrigine	Lamotrigine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1514	Lamotrigine	Lamotirigine	Cadila Healthcare Limited	ANDA	Current
70771-1514	Lamotrigine	Lamotirigine	Zydus Lifesciences Limited	ANDA	Current
70771-1515	Lamotrigine	Lamotirigine	Zydus Lifesciences Limited	ANDA	Current
70771-1515	Lamotrigine	Lamotirigine	Cadila Healthcare Limited	ANDA	Current
70771-1516	Lamotrigine	Lamotirigine	Cadila Healthcare Limited	ANDA	Current
70771-1516	Lamotrigine	Lamotirigine	Zydus Lifesciences Limited	ANDA	Current
70771-1517	Lamotrigine	Lamotirigine	Cadila Healthcare Limited	ANDA	Current
70771-1517	Lamotrigine	Lamotirigine	Zydus Lifesciences Limited	ANDA	Current
70771-1518	Lamotrigine	Lamotirigine	Cadila Healthcare Limited	ANDA	Current
70771-1518	Lamotrigine	Lamotirigine	Zydus Lifesciences Limited	ANDA	Current
70771-1519	Lamotrigine	Lamotirigine	Cadila Healthcare Limited	ANDA	Current
70771-1519	Lamotrigine	Lamotirigine	Zydus Lifesciences Limited	ANDA	Current

Application 207763

Related Records#

Application Products#

NDC Listings For This Application#