Application 078428

Type: ANDA
Sponsor: AMNEAL PHARMS NY

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	TE codes	Approval date
A078428-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25
A078428-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25
A078428-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078428-001	AB
A078428-002	AB
A078428-003	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 · 129 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	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2007-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2007-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2007-07-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078428-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078428-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078428-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078428-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078428-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078428-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078428-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078428-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078428-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078428-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078428-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078428-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078428-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078428-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078428-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078428-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078428-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078428-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078428-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078428-001	AB	1	`301d65b070ca…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54dc347e-cba0-ea73-e063-6294a90ab436	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Amneal Pharmaceuticals LLC	507bf6d0-e7a2-413d-9848-cd2445a1411d	2026-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428 ndc (product): 65162-102 ndc (product): 65162-103 ndc (product): 65162-101
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	7b404ab9-8a7e-49d4-920f-487875d14e45	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	657349fb-41a9-4814-b4ac-4c5afbdde947	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428 ndc (product): 71335-0214
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a15d5dcc-63c4-4c06-ab91-5e22cdf234cc	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428 ndc (product): 71335-0220
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	477691f5-0591-4544-840a-ac590e1f25a1	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428 ndc (product): 71335-0820
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	506bf880-9564-404c-951a-703797ffdad8	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Clinical Solutions Wholesale, LLC	dbedccfb-0e27-4119-93b9-241c039e045a	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428
Gabapentin	GABAPENTIN	Amneal Pharmaceuticals of New York LLC	b11dbff5-ceee-4a63-a093-f6efebdc2f6f	2021-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078428 application number: ANDA078428

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 2 of 2 · 126 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63739-984	Gabapentin	Gabapentin	Mckesson Corporation DBA SKY Packaginng	ANDA	Current
63739-984	Gabapentin	Gabapentin	McKesson Corporation dba SKY Packaging	ANDA	Current
65162-101	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-101	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-101	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-101	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-101	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-101	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-102	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-102	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-102	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-102	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-102	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-102	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-103	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-103	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-103	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-103	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-103	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
65162-103	Gabapentin	Gabapentin	Amneal Pharmaceuticals LLC	ANDA	Current
67046-223	Gabapentin	Gabapentin	Contract Pharmacy Services-PA	ANDA	Current
67046-224	Gabapentin	Gabapentin	Contract Pharmacy Services-PA	ANDA	Current
68071-4090	Gabapentin	Gabapentin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4169	Gabapentin	Gabapentin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68387-404	Gabapentin	Gabapentin	Keltman Pharmaceuticals Inc.	ANDA	Current
68387-410	Gabapentin	Gabapentin	Keltman Pharmaceuticals Inc.	ANDA	Current
68387-420	Gabapentin	Gabapentin	Keltman Pharmaceuticals Inc.	ANDA	Current
68788-9325	Gabapentin	Gabapentin	Preferred Pharmaceuticals, Inc.	ANDA	Current
69189-0614	Gabapentin	Gabapentin	Avera McKennan Hospital	ANDA	Current
69336-106	Gabapentin	Gabapentin	Sterling Knight Pharmaceuticals,LLC	ANDA	Current
69677-208	Gabapentin	Gabapentin	Mas Management Group, Inc.	ANDA	Current
70518-1288	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-1288	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-1288	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-1288	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-1288	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
71335-0214	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-0214	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-0214	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-0220	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-0220	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-0220	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-0820	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-0820	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-0820	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-0820	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current