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 5 of 19 · 380 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Pangea Pharmaceuticals, LLC	5eff7ad8-0d31-4372-82a2-ac9f549d8796	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	397fd6d3-317b-4b61-a52b-3a09ca1d88a4	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	13640281-26b4-402e-8f69-7c81cd6e0376	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Amici Pharma, Inc.	1ea83c18-7107-41f4-8305-62725c1c45c8	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	d4f21e97-5e55-44c9-9b31-5f79ac2eb512	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Neurontin	GABAPENTIN	Viatris Specialty LLC	97935fd9-1d4a-43b6-a5d9-de994591187b	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	eeb19a5a-b31d-4df8-9546-0b2b5eb5db07	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Major Pharmaceuticals	152adf1d-ec0c-4561-bf80-e4c7da158723	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Major Pharmaceuticals	999f3685-2eac-467e-bed2-1d0c36aaf0ed	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	35da078b-0da0-4757-a6c4-a9144c37e8e1	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	38119f2e-33b3-4c3c-99b7-9335d8d280d4	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	b8b7e045-a7fe-8539-e053-2a95a90a40f8	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St Mary's Medical Park Pharmacy	de990f96-96bc-406d-e053-2995a90abebb	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	4cb26d6e-7963-4fe5-903e-ab5180545066	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	100ff86c-56a8-4770-9db3-b9bc6b1bd2f7	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	d22ed424-f365-44ca-8ef9-a08255a90ae8	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	e3429322-c442-4146-bb68-bcc3a8d01552	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	2625c0ef-5295-41de-9e81-88001a6cbecc	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	6ecf5114-2ddc-4025-a36d-1884702dc22a	2026-04-29	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.