Application 207057

Type: ANDA
Sponsor: CSPC OUYI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	TABLET;ORAL	600MG	No	No
002	GABAPENTIN	GABAPENTIN	TABLET;ORAL	800MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207057-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2017-10-26
A207057-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2017-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207057-001	AB1
A207057-002	AB1

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2017-10-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2017-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207057-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2017-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207057-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2017-10-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A207057-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207057-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207057-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207057-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207057-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207057-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207057-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207057-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207057-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207057-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207057-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207057-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207057-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207057-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207057-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207057-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207057-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207057-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207057-001	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207057-002	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207057-001	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207057-002	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207057-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207057-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207057-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207057-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207057-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207057-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207057-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207057-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207057-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207057-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207057-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207057-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207057-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207057-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207057-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207057-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207057-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A207057-002	AB	1	`f41ea6bd6efb…`

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 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Coupler LLC	5954a330-c225-00bd-e063-6294a90a7581	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	TAGI Pharma, Inc.	725878fa-1e2f-4fee-a9e1-a6e102c79625	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057 ndc (product): 51224-021 ndc (product): 51224-121
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d8604417-9d43-4d27-a7ce-d4120ff201f4	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057 ndc (product): 71335-1287
Gabapentin	GABAPENTIN	A-S Medication Solutions	b88b0cbc-c883-4d17-8f46-0e5bddc57835	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	A-S Medication Solutions	081fd1de-acaa-4685-a053-4959d77b17e9	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Precision Dose, Inc.	021329d0-7d32-4fd8-81bf-a8b0d8b49e43	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	A-S Medication Solutions	b74a427c-9cc1-4b15-9ed2-cc891741fe67	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Mullan Pharmaceutical Inc.	47a22de2-ec66-45be-8648-89ed3ab6e67e	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Precision Dose, Inc.	86c93d8b-6286-44e2-93dd-f1b10a5d83da	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Proficient Rx LP	87b9171b-7d00-40fa-87ff-a717740efe8a	2025-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	07871ab8-254b-e3c2-e063-6294a90a29ab	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals, Inc.	2c65253d-ca49-70eb-e063-6394a90a3cd2	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	AvPAK	faa47fcd-2545-a946-e053-6294a90a05d2	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	ec1a01fe-5531-21df-e053-2a95a90a0561	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057 ndc (product): 80425-0201 ndc (product): 80425-0204
Gabapentin	GABAPENTIN	Westminster Pharmaceuticals, LLC	2eec52a1-9016-46dd-8b4c-8dab1d0aeece	2024-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207057 application number: ANDA207057 ndc (product): 69367-346 ndc (product): 69367-347

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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4445	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-4445	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-5331	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
51224-021	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-021	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-021	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-021	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-121	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-121	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-121	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-121	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
69367-346	Gabapentin	Gabapentin	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-347	Gabapentin	Gabapentin	Westminster Pharmaceuticals, LLC	ANDA	Current
70518-2960	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-2960	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-2960	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-2960	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-2960	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
71335-1287	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1287	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71717-102	GABAPENTIN	GABAPENTIN	Megalith Pharmaceuticals Inc	ANDA	Current
71717-103	GABAPENTIN	GABAPENTIN	Megalith Pharmaceuticals Inc	ANDA	Current
80425-0201	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0204	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current