Application 075477

Type: ANDA
Sponsor: CSPC OUYI

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 1.

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	TE codes	Approval date
A075477-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23
A075477-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23
A075477-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075477-001	AB
A075477-002	AB
A075477-003	AB

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 · 123 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
2026-02-19 14:30 UTC	2026-02	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075477-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2005-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075477-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2005-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075477-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2005-03-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075477-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075477-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075477-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075477-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075477-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075477-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075477-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075477-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075477-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075477-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075477-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075477-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075477-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075477-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075477-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075477-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075477-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075477-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075477-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075477-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075477-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075477-001	AB	1	`8072bd15b7f6…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Proficient Rx LP	9d401e54-d4f5-43ba-b898-dd08fc3c7bfa	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Mullan Pharmaceutical Inc.	74474aa4-4859-42d2-92d8-f23f18b34e04	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Proficient Rx LP	3c8dca11-78ab-45c1-8bb2-89a41ea5dfa9	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Westminster Pharmaceuticals, LLC	3ad96553-73a4-4a9b-8a89-10a29b794ed3	2025-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477 ndc (product): 69367-345 ndc (product): 69367-344 ndc (product): 69367-343
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	0919fed8-e968-b5ac-e063-6294a90afbff	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	ec1c621b-db2a-1567-e053-2995a90a8695	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477 ndc (product): 80425-0199
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	ebf57adf-b066-2959-e053-2a95a90a961c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477 ndc (product): 80425-0196
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	f781d400-7304-5d3e-e053-6294a90ac572	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075477 application number: ANDA075477

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5322	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
51224-019	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-019	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-019	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-119	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-119	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-119	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-219	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-219	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
51224-219	Gabapentin	Gabapentin	TAGI Pharma, Inc.	ANDA	Current
69367-343	Gabapentin	Gabapentin	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-344	Gabapentin	Gabapentin	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-345	Gabapentin	Gabapentin	Westminster Pharmaceuticals, LLC	ANDA	Current
70518-3140	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
80425-0149	Neurotin	Gabapentin 300mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0149	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0149	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0196	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0199	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current