Application 079153

Type: ANDA
Sponsor: TORRENT PHARMS

Related Records

Company: TORRENT PHARMS

Application Products

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

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-031	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-031	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-031	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-031	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-032	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-032	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-032	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-032	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-033	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-033	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-033	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-033	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-034	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-034	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-034	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-034	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
43063-094	TOPIRAMATE	topiramate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-094	TOPIRAMATE	topiramate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-538	TOPIRAMATE	topiramate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-538	TOPIRAMATE	topiramate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
52959-441	TOPIRAMATE	topiramate	H.J. Harkins Company, Inc.	ANDA	Current
52959-994	TOPIRAMATE	topiramate	H.J. Harkins Company, Inc.	ANDA	Current
61919-185	TOPIRAMATE	topiramate tablet	DIRECT RX	ANDA	Current
61919-825	TOPIRAMATE	TOPIRAMATE	DIRECT RX	ANDA	Current
61919-825	TOPIRAMATE	TOPIRAMATE	DIRECT RX	ANDA	Current
68788-9730	TOPIRAMATE	topiramate	Preferred Pharmaceuticals	ANDA	Current

Documents

Document	Submission type	Date
44402	ORIG	2009-04-14
9227	ORIG	2009-04-01