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 13 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	febf610e-e088-4797-e053-6294a90a3eb5	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	07871ab8-254b-e3c2-e063-6294a90a29ab	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	0919fed8-e968-b5ac-e063-6294a90afbff	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a1ff94a9-69c4-486a-aab2-563c7ed244c8	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Coupler LLC	2cdbb381-88a2-5c5a-e063-6294a90a3e1e	2025-01-29	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals, Inc.	2c65253d-ca49-70eb-e063-6394a90a3cd2	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Direct_Rx	e90d2e3d-ec86-7d1d-e053-2995a90a9167	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Direct_Rx	ed9cb5fe-7a2e-e0bc-e053-2a95a90a4470	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Direct_Rx	f40a4ee4-ae8e-769c-e053-2a95a90a344e	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Directrx	d5c9dd2c-b8ee-1406-e053-2995a90a0287	2025-01-21	Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals Inc.	db57e37f-0a78-4c14-8768-a28bbf9fa0da	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	DIRECT RX	a5b47f89-ed35-31de-e053-2a95a90a5554	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	DIRECT RX	a7e45e3f-e382-32ba-e053-2a95a90a2537	2025-01-17		Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Clinical Solutions Wholesale, LLC	743faa18-5e7c-4fcc-9781-4157450d90c4	2025-01-16	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	bd5c9279-a1e3-2a59-e053-2a95a90a33a2	2025-01-14	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	41ce952c-6c16-4b5d-adf7-9ea114e63eb3	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	13b87441-8fe1-40f5-8ffb-00dcd8cc90a6	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	AvPAK	faa47fcd-2545-a946-e053-6294a90a05d2	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	95757436-2093-41cf-a9a9-ef2f28ac096f	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	NuCare Pharmaceuticals,Inc.	2b395a14-0f8e-7f5b-e063-6294a90ab546	2025-01-08	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