Application 077261

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	100MG	No	No
002	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	300MG	No	No
003	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077261-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	2013-08-02
A077261-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	2013-08-02
A077261-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	2013-08-02

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 · 129 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
2026-09-14 22:38:34	2026-08	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL		2013-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077261-002	GABAPENTIN	300MG	CAPSULE / ORAL		2013-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077261-003	GABAPENTIN	400MG	CAPSULE / ORAL		2013-08-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL		2013-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077261-002	GABAPENTIN	300MG	CAPSULE / ORAL		2013-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077261-003	GABAPENTIN	400MG	CAPSULE / ORAL		2013-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL		2013-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077261-002	GABAPENTIN	300MG	CAPSULE / ORAL		2013-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077261-003	GABAPENTIN	400MG	CAPSULE / ORAL		2013-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL		2013-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077261-002	GABAPENTIN	300MG	CAPSULE / ORAL		2013-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077261-003	GABAPENTIN	400MG	CAPSULE / ORAL		2013-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2013-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077261-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2013-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077261-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2013-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2013-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077261-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2013-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077261-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2013-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2013-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077261-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2013-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077261-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2013-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2013-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077261-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2013-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077261-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2013-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2013-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077261-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2013-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077261-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2013-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2013-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077261-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2013-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077261-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2013-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2013-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077261-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2013-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077261-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2013-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2013-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077261-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2013-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077261-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2013-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2013-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077261-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2013-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077261-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2013-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077261-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2013-08-02	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A077261-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077261-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077261-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077261-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077261-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077261-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077261-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077261-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077261-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077261-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077261-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077261-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077261-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077261-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077261-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077261-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077261-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077261-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077261-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077261-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077261-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077261-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077261-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077261-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077261-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077261-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077261-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077261-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077261-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077261-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077261-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077261-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077261-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077261-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077261-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077261-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077261-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077261-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077261-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077261-001	AB	1	`5d02ea3f76ae…`

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 17 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	9efd0261-9fc9-4dc9-8cf3-9110157ddfc4	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	b4954172-5439-48fd-8348-8a2e0d2fee62	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	01b810b7-f4c8-4412-bbc5-b9220d8770d8	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	c9944562-563a-423d-972c-f0313375d234	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Medsource Pharmaceuticals	12f0c2ee-9a44-9778-e063-6294a90a3b58	2024-03-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	1749d731-bc8c-4374-b2a9-7c809c457f56	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Medsource Pharmaceuticals	1278512b-1493-db65-e063-6394a90ab161	2024-02-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	7a2aa696-7dac-4d03-916a-374b61a255b5	2024-02-16	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	79cd9dea-e7d0-44db-afba-964cb99f32b6	2024-01-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	f9bf87e4-5499-4dd7-a0c1-16025a718d14	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	f38098ec-dd1a-405a-bbfb-bad62e4e7fa5	2024-01-04	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	56967a93-b3c0-4043-9241-585fc64e2624	2023-12-20	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	e286ed87-5fbc-4ff2-a05e-1f7fa658bbfc	2023-12-20	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	0eb27e64-1488-4083-82c7-cebb8c0605de	2023-12-20	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	ecb798a0-377d-4712-bb82-ec9d7116962f	2023-12-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	40bb60c0-a2f3-4e7f-b13c-028c906c4852	2023-11-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	9c96b488-19bd-431e-af9a-b313ffd9eaae	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	5fb79774-c2d4-47ba-9a16-eb367d0fdcff	2023-09-30	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	af62bb7e-162e-4e2a-8eb0-d50f66678707	2023-09-22	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	77d1d90d-e124-4db7-b811-754d535e579c	2023-09-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.