Application 077662

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	TABLET;ORAL	600MG	No	No
002	GABAPENTIN	GABAPENTIN	TABLET;ORAL	800MG	No	No

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

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
A077662-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2006-08-18
A077662-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2006-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077662-001	AB1
A077662-002	AB1

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 · 86 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	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077662-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-08-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077662-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-08-18	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077662-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077662-002	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077662-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077662-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077662-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077662-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077662-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077662-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077662-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077662-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077662-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077662-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077662-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077662-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077662-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077662-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077662-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077662-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077662-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077662-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077662-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077662-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077662-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077662-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077662-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077662-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077662-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077662-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077662-002	AB	1	`74a2ff9319b5…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Clinical Solutions Wholesale, LLC	b7f9a106-52c6-49e4-acf5-8fb07761ba4f	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Coupler LLC	583ab038-7b6e-96f8-e063-6294a90adf47	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54edd6f3-06c7-a0c7-e063-6394a90a8b4f	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	4cb26d6e-7963-4fe5-903e-ab5180545066	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	BluePoint Laboratories	3368bf70-d466-4765-b2b7-7fe967a8c2b7	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	632cb507-5675-2392-0460-b09c0dd14650	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Glenmark Pharmaceuticals Inc., USA	3865a6e3-112c-490c-82ac-35401336b16e	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	137b2b9a-9d42-48d0-913f-5dc146fb689a	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2278ce1b-1c19-4ad2-89c6-4530f7b78ea7	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662 ndc (product): 71335-0254
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	7c3b232a-3e9f-4249-9e5a-295482ee288a	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662
Gabapentin	GABAPENTIN	Proficient Rx LP	c78f528f-9192-4037-bfb9-ff5718ed26c5	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077662 application number: ANDA077662

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 93 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68788-9757	Gabapentin	Gabapentin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9757	Gabapentin	Gabapentin	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0140	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-0140	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-0140	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-0278	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-0278	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-0278	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-1807	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-1807	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
71335-0254	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-0254	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-0254	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current