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 15 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	1fd95278-842f-4bf9-abd5-4d9aa858d36d	2024-12-10	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	97a1d45d-d5b3-4be7-9b3a-cb6f80f60291	2024-12-09	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	481e6b68-50e4-4594-9815-32580a84ab8c	2024-12-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Zydus Lifesciences Limited	b033c169-4943-4ad9-ace0-7e4a1f0dc100	2024-11-30		Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	17a62334-209d-4dc1-867a-e5780196a2ca	2024-11-05	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	a072d5d2-8c75-59cc-e053-2a95a90ac0cc	2024-11-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	7b404ab9-8a7e-49d4-920f-487875d14e45	2024-11-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	c33c4d83-cc13-4104-9e24-d4cd40b17b70	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	e2d9bd8c-3bb9-4945-8e61-7d2703d9008c	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	5769d849-4f27-4701-97ec-7e3ca07339d7	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Westminster Pharmaceuticals, LLC	2f70c496-b58c-30f5-e054-00144ff8d46c	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	78088f6a-06a3-422f-b336-4a57a24adc16	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	657349fb-41a9-4814-b4ac-4c5afbdde947	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a15d5dcc-63c4-4c06-ab91-5e22cdf234cc	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	477691f5-0591-4544-840a-ac590e1f25a1	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	506bf880-9564-404c-951a-703797ffdad8	2024-10-29	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	77754734-4125-42b1-97c8-458bcab2bcf1	2024-10-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	fb0b6613-57d6-4e24-946f-f5f87c460cf0	2024-10-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ef37f2a0-3b83-4f71-91c0-6435161b483c	2024-10-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ff28c5f1-da56-4072-a6fa-d689d4a6761b	2024-10-07	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