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 11 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Exelan Pharmaceuticals, Inc.	a88edb00-2189-4c8d-9dd7-9fe1571775cc	2025-08-16	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	XLCare Pharmaceuticals, Inc.	707ed63a-67ca-4a62-9cbe-cdeb5c4ab506	2025-08-16	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	XLCare Pharmaceuticals, Inc.	618c948d-deee-44e2-98f0-e5232171dd50	2025-08-04	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ca8177ed-1f0d-436e-a5ac-f58b8f7cbb25	2025-07-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2278ce1b-1c19-4ad2-89c6-4530f7b78ea7	2025-07-14	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NorthStar Rx LLC	9508cb1b-3f9f-48bd-8f34-a6fbb68c9a4a	2025-07-11	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
gabapentin	GABAPENTIN	ScieGen Pharmaceuticals, Inc.	3f2e3ac5-5233-fd57-e063-6294a90a849e	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	7c3b232a-3e9f-4249-9e5a-295482ee288a	2025-06-27	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NorthStar Rx LLC	f7c1fd34-d615-43a2-8989-898fe11f90df	2025-06-25	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	d25daaac-a8ab-4f12-acc2-4ec8fc97a2d4	2025-06-24	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	QUALLENT PHARMACEUTICALS HEALTH LLC	472bb279-bb4e-4246-b2a3-172483ba356b	2025-06-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals, Inc.	5d3f27bf-3486-40fa-a4d3-5f0b2c6c0151	2025-06-11	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals, Inc.	561f53d5-5301-42b3-b372-f3d49d642a2e	2025-06-11	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Direct_Rx	ed9c501c-24e4-da89-e053-2a95a90a64c6	2025-06-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	11645bd6-7cfe-49b2-9292-2e4b0dbb84ae	2025-06-04	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
gabapentin	GABAPENTIN	Rising Pharma Holdings, Inc.	969cccfc-e56a-49da-9d36-47c0c3fad7f8	2025-06-03	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	PAI Holdings, LLC dba PAI Pharma	6d3fd1f9-c831-4262-af10-291838a53541	2025-05-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Rising Pharma Holdings, Inc.	8215da86-d7af-4980-b6d6-4bd46f6bfeaf	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	ATLANTIC BIOLOGICALS CORP.	5969f1a8-d6d5-4967-add5-4e2492354d7b	2025-05-27	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Camber Pharmaceuticals, Inc.	0ce53f62-1738-43f4-9a2e-c5dc42a91d09	2025-05-26	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