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 16 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Direct_Rx	fbc05ceb-2e69-3c37-e053-6394a90ac4f4	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2dad630a-09d8-4f40-bdad-24e877a9ee38	2024-09-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Creekwood Pharmaceuticals LLC	26aac429-a5cd-33cc-e063-6394a90aecc0	2024-09-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Creekwood Pharmaceuticals LLC	266ef369-0a56-f225-e063-6294a90a495e	2024-09-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1e28ad3d-2d34-a5d0-e063-6294a90adb9e	2024-07-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	a9c99dfa-f54d-9207-e053-2995a90ad43b	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	a9f0852e-0c58-ba22-e053-2995a90adfa0	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb	2024-07-08	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	8f785189-bf66-36cc-e053-2a95a90a7cbc	2024-06-19		Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	8e6ed5d2-40e0-1f06-e053-2a95a90aa40e	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	82c0ed15-9132-657d-e053-2991aa0ae90a	2024-06-14		Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ffe5321d-3405-46d5-a75f-c51e8f8d87b1	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Clinical Solutions Wholesale, LLC	934fefae-b895-427c-8798-4c5462b1ecc2	2024-04-11	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	ed219efc-84e3-5bdc-e053-2a95a90a56fc	2024-04-11	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Clinical Solutions Wholesale, LLC	dbedccfb-0e27-4119-93b9-241c039e045a	2024-04-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	47f2a06f-4eac-4dca-aa2a-a36dd4daaea0	2024-04-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	38210141-bbdc-4186-b71f-54c72f794dca	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	75418d32-6504-4cb4-b3a9-afa0eaf19b8d	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	1ec656c9-034f-4f14-9e6b-9779d41e1627	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	8de89818-805a-4a20-a9b1-48cf443b6315	2024-04-03	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