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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020646-001	GABITRIL	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30
N020646-002	GABITRIL	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	RLD	1997-09-30
N020646-003	GABITRIL	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	RLD	1997-09-30
N020646-004	GABITRIL	TIAGABINE HYDROCHLORIDE	20MG	TABLET / ORAL			1997-09-30
N020646-005	GABITRIL	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	RLD	1999-04-16
N020646-006	GABITRIL	TIAGABINE HYDROCHLORIDE	6MG	TABLET / ORAL			2005-11-29
N020646-007	GABITRIL	TIAGABINE HYDROCHLORIDE	8MG	TABLET / ORAL			2005-11-29
N020646-008	GABITRIL	TIAGABINE HYDROCHLORIDE	10MG	TABLET / ORAL			2005-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N020646-001	AB
N020646-002	AB
N020646-003	AB
N020646-005	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-001	GABITRIL	4MG	TABLET / ORAL	AB	RLD, RS	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-002	GABITRIL	12MG	TABLET / ORAL	AB	RLD	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-003	GABITRIL	16MG	TABLET / ORAL	AB	RLD	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-004	GABITRIL	20MG	TABLET / ORAL			1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-005	GABITRIL	2MG	TABLET / ORAL	AB	RLD	1999-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-006	GABITRIL	6MG	TABLET / ORAL			2005-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-007	GABITRIL	8MG	TABLET / ORAL			2005-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-008	GABITRIL	10MG	TABLET / ORAL			2005-11-29	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020646-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020646-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020646-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020646-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020646-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020646-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020646-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020646-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020646-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020646-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020646-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020646-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020646-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020646-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020646-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020646-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020646-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020646-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020646-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020646-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020646-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020646-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020646-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020646-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020646-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020646-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020646-005	AB	1	`d06236e962d9…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tiagabine Hydrochloride	TIAGABINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	953ef3cc-e3cb-480f-b9ea-256520fd62b8	2021-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020646 application number: NDA020646 ndc (product): 0093-8072 ndc (product): 0093-5031 ndc (product): 0093-8076 ndc (product): 0093-5030

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 65 matching rows.

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, 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, LLC	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, 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, LLC	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