Application 207382

Type: ANDA
Sponsor: ZYDUS PHARMS

Related Records

Company: ZYDUS PHARMS

Application Products

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

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-769	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-769	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-769	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-769	Topiramate	Topiramate	Zydus Pharmaceuticals (US	ANDA	Current
68382-769	Topiramate	Topiramate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-863	Topiramate	Topiramate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-863	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-863	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-863	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-863	Topiramate	Topiramate	Zydus Pharmaceuticals (US	ANDA	Current
68382-864	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-864	Topiramate	Topiramate	Zydus Pharmaceuticals (US	ANDA	Current
68382-864	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-864	Topiramate	Topiramate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-864	Topiramate	Topiramate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1315	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1315	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1315	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1315	Topiramate	Topiramate	Zydus Lifesciences Limited	ANDA	Current
70771-1316	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1316	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1316	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1316	Topiramate	Topiramate	Zydus Lifesciences Limited	ANDA	Current
70771-1317	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1317	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1317	Topiramate	Topiramate	Cadila Healthcare Limited	ANDA	Current
70771-1317	Topiramate	Topiramate	Zydus Lifesciences Limited	ANDA	Current

Documents

Document	Title	Submission type	Submission no.	Date
50732	0	ORIG	1	2017-12-18