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 7 of 19 · 380 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Radha Pharmaceuticals, Inc.	1045db4e-4c76-4a0d-bf12-019bd96a8f59	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Direct_Rx	0b286fd1-8179-d87a-e063-6294a90a2f23	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	American Health Packaging	e00f5048-1a06-44f4-b244-aa2755f4be22	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Solco Healthcare US, LLC	360d953b-4313-45ae-b933-296547d4577d	2026-02-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	54c09aa5-6724-480a-a115-c88484e39e93	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advagen Pharma Ltd	401b30fc-e143-4906-aae1-e5b5c190d4a8	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advagen Pharma Ltd	bfee67dc-d2b1-4a00-92d9-a42be3189c74	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	9814b76c-87c6-4746-b712-3269352a901b	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	c979f80b-d4b1-40f7-b878-b216db5f325d	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	b88b0cbc-c883-4d17-8f46-0e5bddc57835	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	3dbd447f-4791-4c62-86b4-6f7928862785	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	081fd1de-acaa-4685-a053-4959d77b17e9	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	2343e3a1-82d0-4c70-a086-a01a0ce81ef3	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	67330eef-c976-4862-b1ae-20f30f43df76	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	2e331641-ec26-4d76-b16b-a9863c767afe	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	cc1998a7-7004-4688-8b5b-525041851d1d	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	4aa69d04-6b32-4764-a48b-ef5313dd95d3	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	60b46f6d-efbc-487a-b672-b20df8b44cc4	2026-01-23	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.