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 8 of 19 · 380 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	43a3ec78-8235-4d46-a343-2f9226745a39	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	685553b0-384e-400b-a8ae-612ceece8261	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	7ea0b220-edbb-45eb-aeb3-65283f8489a1	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals, Inc.	bff3beea-1f05-4e84-bcd2-d05782acddae	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	DIRECT RX	29a70e2d-d3fd-4e32-95dd-7ee721d87388	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
gabapentin	GABAPENTIN	Coupler LLC	47cd25f6-e123-9aaf-e063-6394a90aeedd	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
GABARONE	GABAPENTIN	INA Pharmaceutics Inc.	0f350a4b-f294-4b98-b69f-3cc789e930ba	2026-01-07	Warnings, Adverse reactions	Name fallback generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Ajenat Pharmaceuticals LLC	02304deb-7b4a-452f-9b1a-64ca0aedbcc2	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
gabapentin	GABAPENTIN	Northwind Health Company, LLC	471b2d32-0cbd-aade-e063-6394a90a1696	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	ST. MARY'S MEDICAL PARK PHARMACY	3aaf3d6e-c6d5-89f5-e063-6394a90a9b77	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Northwind Health Company, LLC	47214c7c-ba1b-9107-e063-6294a90a5431	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	BioComp Pharma, Inc.	0b3a4009-42f3-c84f-e063-6294a90a8068	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Camber Pharmaceuticals, Inc.	b86c81d9-9a4a-4847-be18-520e5cc5dc4b	2025-12-12	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	JVET PHARMACEUTICALS LLC	63a5fc6d-ca57-4726-b70d-805ac023d959	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Glenmark Pharmaceuticals Inc., USA	3865a6e3-112c-490c-82ac-35401336b16e	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Precision Dose, Inc.	021329d0-7d32-4fd8-81bf-a8b0d8b49e43	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Redpharm Drug	44f2b497-55b2-864f-e063-6294a90ad6d5	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Kesin Pharma Corporation	4470a567-93a6-a293-e063-6394a90affc1	2025-11-25	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	b74a427c-9cc1-4b15-9ed2-cc891741fe67	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Acella Pharmaceuticals, LLC	3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa2	2025-11-03	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.