Application 214816

Type: ANDA
Sponsor: MSN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	TABLET;ORAL	2MG	No	No
002	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	TABLET;ORAL	4MG	No	No
003	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	TABLET;ORAL	12MG	No	No
004	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	TABLET;ORAL	16MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214816-001	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2021-11-16
A214816-002	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2021-11-16
A214816-003	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	2021-11-16
A214816-004	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	2021-11-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214816-001	AB
A214816-002	AB
A214816-003	AB
A214816-004	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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214816-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2021-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214816-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2021-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214816-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	2021-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214816-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	2021-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214816-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2021-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214816-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2021-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214816-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	2021-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214816-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	2021-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214816-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2021-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214816-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2021-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214816-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	2021-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214816-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	2021-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214816-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2021-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214816-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2021-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214816-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	2021-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214816-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	2021-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214816-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2021-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214816-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2021-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214816-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	2021-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214816-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	2021-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214816-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2021-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214816-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2021-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214816-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	2021-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214816-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	2021-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214816-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2021-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214816-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2021-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214816-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	2021-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214816-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	2021-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214816-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2021-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214816-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2021-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214816-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	2021-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214816-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	2021-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214816-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2021-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214816-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2021-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214816-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	2021-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214816-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	2021-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214816-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2021-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214816-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2021-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214816-003	TIAGABINE HYDROCHLORIDE	12MG	TABLET / ORAL	AB	2021-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214816-004	TIAGABINE HYDROCHLORIDE	16MG	TABLET / ORAL	AB	2021-11-16	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 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	A214816-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214816-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214816-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214816-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214816-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214816-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214816-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214816-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214816-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214816-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214816-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214816-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214816-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214816-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214816-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214816-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214816-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214816-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214816-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214816-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214816-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214816-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214816-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214816-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214816-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214816-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214816-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214816-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214816-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214816-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214816-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214816-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214816-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214816-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214816-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214816-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214816-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214816-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214816-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214816-004	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	Novadoz Pharmaceuticals LLC	7c034fe0-cdac-49e1-8e39-592846ea3bec	2021-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214816 application number: ANDA214816 ndc (product): 72205-087 ndc (product): 72205-085 ndc (product): 72205-086 ndc (product): 72205-084

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-151	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Northstar Rx LLC	ANDA	Current
16714-152	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Northstar Rx LLC	ANDA	Current
16714-153	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Northstar Rx LLC	ANDA	Current
16714-154	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Northstar Rx LLC	ANDA	Current
72205-084	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-085	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-086	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-087	Tiagabine Hydrochloride	Tiagabine Hydrochloride	Novadoz Pharmaceuticals LLC	ANDA	Current