Application 077555

Type: ANDA
Sponsor: SUN PHARM INDS

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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077555-001	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL			2011-11-04
A077555-002	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL			2011-11-04

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 3 · 82 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	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL		2011-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL		2011-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL		2011-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL		2011-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL		2011-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL		2011-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077555-001	TIAGABINE HYDROCHLORIDE	2MG	TABLET / ORAL	AB	2011-11-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077555-002	TIAGABINE HYDROCHLORIDE	4MG	TABLET / ORAL	AB	2011-11-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077555-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077555-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077555-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077555-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077555-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077555-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077555-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077555-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077555-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077555-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077555-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077555-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077555-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077555-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077555-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077555-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077555-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077555-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077555-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077555-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077555-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077555-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077555-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077555-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077555-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077555-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077555-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077555-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077555-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077555-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077555-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077555-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077555-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077555-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077555-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077555-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077555-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077555-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077555-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077555-002	AB	1	`8869cabd3fbd…`

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	Sun Pharmaceutical Industries, Inc.	7eeb2d81-c5d7-46a0-aa5c-149b55df71bd	2018-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077555 application number: ANDA077555 ndc (product): 62756-200 ndc (product): 62756-224

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62756-200	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-224	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9058	ORIG	2011-11-10