Application 217116

Type: ANDA
Sponsor: GRANULES

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 45.

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
A217116-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2023-03-28
A217116-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2023-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217116-001	AB1
A217116-002	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 2 · 54 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
2026-11-14 07:37:17	2026-10	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217116-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2023-03-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217116-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2023-03-28	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	A217116-001	AB1	1	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A217116-002	AB1	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A217116-001	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A217116-002	AB1	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217116-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217116-002	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217116-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217116-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217116-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217116-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217116-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217116-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217116-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217116-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217116-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217116-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217116-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217116-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217116-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217116-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217116-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217116-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217116-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217116-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217116-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217116-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217116-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217116-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217116-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217116-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217116-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217116-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217116-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217116-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217116-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217116-002	AB1	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217116-001	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217116-002	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217116-001	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217116-002	AB1	1	`1c564ffb4f44…`

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 6 of 19 · 380 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	f396ec70-826d-45c6-a27c-343c2fac878c	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals, Inc.	41dcc917-68d1-49f0-8223-44c21ca259ef	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Coupler LLC	5073abda-321f-29d1-e063-6394a90a59ac	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	BluePoint Laboratories	3368bf70-d466-4765-b2b7-7fe967a8c2b7	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Coupler LLC	500ee820-0378-6fc9-e063-6394a90a109c	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	dd0e12c2-1986-4ca3-a809-d703a7542419	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	PHOENIX RX LLC	4f95c01f-200e-bfd7-e063-6394a90abc38	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ce0f0d7f-da6d-47da-a4ed-fb8f72902412	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	abb56036-88df-4720-ba78-529971671545	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a75c9157-a1fc-44cc-89f8-c5a3742fb9ed	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d1aa4690-57b5-4a3e-ac12-85f777dbd05e	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
RELGAABI	GABAPENTIN	Method Pharmaceuticals, LLC	4cc6615b-5447-9c0e-e063-6394a90a2883	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	632cb507-5675-2392-0460-b09c0dd14650	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Strides Pharma Science Limited	798575b9-ddfa-4915-9574-626abbaf025f	2026-04-04	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	75caca13-1432-4c0d-8d45-f029b0b2d417	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	56378630-e7a7-4981-8212-8ea703a433d8	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	ST. MARY'S MEDICAL PARK PHARMACY	4ddc1342-5c83-f562-e063-6294a90a29ba	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afc83432-8fce-6d2a-e053-2a95a90ae73f	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	81774da8-cb1d-4c7d-8550-35396850d5ff	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	912d8697-b466-48dc-88d3-d2ba90e76644	2026-03-12	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.