Application 091008

Type: ANDA
Sponsor: JIANGSU HENGRUI MED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	100MG	No	No
002	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	300MG	No	No
003	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091008-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26
A091008-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26
A091008-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091008-002	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091008-003	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091008-002	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091008-003	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091008-002	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091008-003	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091008-002	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091008-003	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091008-002	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091008-003	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091008-002	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091008-003	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091008-002	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091008-003	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091008-002	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091008-003	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091008-002	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091008-003	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091008-002	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091008-003	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091008-002	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091008-003	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091008-002	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091008-003	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091008-002	GABAPENTIN	300MG	CAPSULE / ORAL	2017-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091008-003	GABAPENTIN	400MG	CAPSULE / ORAL	2017-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091008-001	GABAPENTIN	100MG	CAPSULE / ORAL	2017-10-26	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091008-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091008-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091008-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A091008-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091008-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091008-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091008-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091008-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091008-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091008-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091008-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091008-003	AB	1	`ea99ee380514…`

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 9 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	Strides Pharma Science Limited	bec31452-b52b-4698-ba4c-0b614780ee84	2025-11-12	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
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	5134369d-c7f6-4569-a425-d50e5a5d694f	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Mullan Pharmaceutical Inc.	47a22de2-ec66-45be-8648-89ed3ab6e67e	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	25befbfa-5125-4363-8306-f862e81c0a6f	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d9d78138-e1e9-4107-9099-4910cb1422d8	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	6e900fc4-a2b3-411f-9ab7-8dcbb97b697b	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	aa246838-609c-4254-a8ec-d6f463a17960	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	efb86e22-5a84-4b33-aad0-71dd5a2c6c8f	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	1ead7343-ab25-41b5-af4f-f903470e1dd9	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	781b0d62-a760-4371-8908-1f61329928a6	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	STALLION LABORATORIES PRIVATE LIMITED	b26fd0c6-6aab-4957-8a32-cc7adb9b5fc9	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	American Health Packaging	bbfdedd7-2baf-4bc6-be59-548a5cf21752	2025-10-03	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57884-2001	Gabapentin	Gabapentin	Jiangsu Hengrui Medicine Co. Ltd.	ANDA	Current
57884-2001	Gabapentin	Gabapentin	Jiangsu Hengrui Medicine Co. Ltd.	ANDA	Current
57884-2001	Gabapentin	Gabapentin	Jiangsu Hengrui Medicine Co. Ltd.	ANDA	Current
57884-2001	Gabapentin	Gabapentin	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	ANDA	Current
57884-2001	Gabapentin	Gabapentin	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	ANDA	Current
57884-2001	Gabapentin	Gabapentin	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	ANDA	Current
57884-2002	Gabapentin	Gabapentin	Jiangsu Hengrui Medicine Co. Ltd.	ANDA	Current
57884-2002	Gabapentin	Gabapentin	Jiangsu Hengrui Medicine Co. Ltd.	ANDA	Current
57884-2002	Gabapentin	Gabapentin	Jiangsu Hengrui Medicine Co. Ltd.	ANDA	Current
57884-2002	Gabapentin	Gabapentin	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	ANDA	Current
57884-2002	Gabapentin	Gabapentin	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	ANDA	Current
57884-2002	Gabapentin	Gabapentin	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	ANDA	Current
57884-2003	Gabapentin	Gabapentin	Jiangsu Hengrui Medicine Co. Ltd.	ANDA	Current
57884-2003	Gabapentin	Gabapentin	Jiangsu Hengrui Medicine Co. Ltd.	ANDA	Current
57884-2003	Gabapentin	Gabapentin	Jiangsu Hengrui Medicine Co. Ltd.	ANDA	Current
57884-2003	Gabapentin	Gabapentin	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	ANDA	Current
57884-2003	Gabapentin	Gabapentin	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	ANDA	Current
57884-2003	Gabapentin	Gabapentin	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	ANDA	Current