Application 020646

Type: NDA
Sponsor: CEPHALON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABITRIL	TIAGABINE HYDROCHLORIDE	TABLET;ORAL	4MG	Yes	Yes
002	GABITRIL	TIAGABINE HYDROCHLORIDE	TABLET;ORAL	12MG	Yes	No
003	GABITRIL	TIAGABINE HYDROCHLORIDE	TABLET;ORAL	16MG	Yes	No
004	GABITRIL	TIAGABINE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No
005	GABITRIL	TIAGABINE HYDROCHLORIDE	TABLET;ORAL	2MG	Yes	No
006	GABITRIL	TIAGABINE HYDROCHLORIDE	TABLET;ORAL	6MG	No	No
007	GABITRIL	TIAGABINE HYDROCHLORIDE	TABLET;ORAL	8MG	No	No
008	GABITRIL	TIAGABINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5030	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5030	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5030	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5030	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5030	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5030	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5030	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5030	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5031	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5031	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5031	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5031	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5031	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5031	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5031	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5031	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8072	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8072	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8072	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8072	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8072	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8072	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8072	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8072	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8076	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8076	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8076	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8076	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8076	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8076	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8076	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-8076	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
63459-402	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-402	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-402	GABITRIL	Tiagabine Hydrochloride	Cephalon, LLC	NDA	Current
63459-402	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-402	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-402	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-402	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-402	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-404	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-404	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-404	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-404	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-404	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-404	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-404	GABITRIL	Tiagabine Hydrochloride	Cephalon, LLC	NDA	Current
63459-404	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-412	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-412	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-412	GABITRIL	Tiagabine Hydrochloride	Cephalon, LLC	NDA	Current
63459-412	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-412	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-412	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-412	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-412	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-416	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-416	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-416	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-416	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-416	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-416	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
63459-416	GABITRIL	Tiagabine Hydrochloride	Cephalon, LLC	NDA	Current
63459-416	GABITRIL	Tiagabine Hydrochloride	Cephalon, Inc.	NDA	Current
68151-4235	GABITRIL	Tiagabine Hydrochloride	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82035	SUPPL	2025-04-28
74755	SUPPL	2023-07-13
73680	SUPPL	2023-03-06
45034	SUPPL	2016-08-09
45020	SUPPL	2016-08-09
12920	SUPPL	2015-11-12
25436	SUPPL	2015-11-09
25437	SUPPL	2012-01-30
43662	ORIG	2010-10-13
25435	SUPPL	2010-10-13
35073	SUPPL	2010-10-11
41520	ORIG	2010-01-07
35072	SUPPL	2009-05-12
2996	SUPPL	2009-05-04
2995	SUPPL	2005-12-06
35071	SUPPL	2005-12-05
44063	ORIG	2005-04-15
35070	SUPPL	2005-02-17
2994	SUPPL	2005-02-17

Application 020646

Related Records#

Application Products#

NDC Listings For This Application#

Documents#