Application 077661

Type: ANDA
Sponsor: RUBICON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
004	GABAPENTIN	GABAPENTIN	TABLET;ORAL	600MG	No	No
005	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
A077661-004	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2006-09-13
A077661-005	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2006-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077661-004	AB1
A077661-005	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	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB1	2006-09-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB1	2006-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077661-004	GABAPENTIN	600MG	TABLET / ORAL	AB	2006-09-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077661-005	GABAPENTIN	800MG	TABLET / ORAL	AB	2006-09-13	`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	A077661-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077661-005	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077661-004	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077661-005	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077661-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077661-005	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077661-004	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077661-005	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077661-004	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077661-005	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077661-004	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077661-005	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077661-004	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077661-005	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077661-004	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077661-005	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077661-004	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077661-005	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077661-004	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077661-005	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077661-004	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077661-005	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077661-004	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077661-005	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077661-004	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077661-005	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077661-004	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077661-005	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077661-004	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077661-005	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077661-004	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077661-005	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077661-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077661-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077661-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077661-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077661-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077661-005	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077661-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077661-005	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Advagen Pharma Ltd	401b30fc-e143-4906-aae1-e5b5c190d4a8	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077661 application number: ANDA077661 ndc (product): 72888-132 ndc (product): 72888-131

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 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-2551	Gabapentin	Gabapentin	Apotex Corp.	ANDA	Current
60505-2551	Gabapentin	Gabapentin	Apotex Corp.	ANDA	Current
60505-2551	Gabapentin	Gabapentin	Apotex Corp.	ANDA	Current
60505-2552	Gabapentin	Gabapentin	Apotex Corp.	ANDA	Current
60505-2552	Gabapentin	Gabapentin	Apotex Corp.	ANDA	Current
60505-2552	Gabapentin	Gabapentin	Apotex Corp.	ANDA	Current
60505-2552	Gabapentin	Gabapentin	Apotex Corp.	ANDA	Current
60505-2552	Gabapentin	Gabapentin	Apotex Corp.	ANDA	Current
68071-3244	Gabapentin	Gabapentin	NuCare Pharmaceuticals, Inc.	ANDA	Current
72888-131	Gabapentin	gabapentin	Advagen Pharma Ltd	ANDA	Current
72888-132	Gabapentin	gabapentin	Advagen Pharma Ltd	ANDA	Current