Application 203643

Type: ANDA
Sponsor: ABON PHARMS LLC

Application Products#

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203643-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB2		2024-09-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203643-001	AB2

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.

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	A203643-001	GABAPENTIN	600MG	TABLET / ORAL	AB2	2024-09-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203643-001	GABAPENTIN	600MG	TABLET / ORAL	AB2	2024-09-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203643-001	GABAPENTIN	600MG	TABLET / ORAL	AB2	2024-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203643-001	GABAPENTIN	600MG	TABLET / ORAL	AB2	2024-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203643-001	GABAPENTIN	600MG	TABLET / ORAL	AB2	2024-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203643-001	GABAPENTIN	600MG	TABLET / ORAL	AB2	2024-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203643-001	GABAPENTIN	600MG	TABLET / ORAL	AB2	2024-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203643-001	GABAPENTIN	600MG	TABLET / ORAL	AB2	2024-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203643-001	GABAPENTIN	600MG	TABLET / ORAL	AB2	2024-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203643-001	GABAPENTIN	600MG	TABLET / ORAL	AB2	2024-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203643-001	GABAPENTIN	600MG	TABLET / ORAL	AB2	2024-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203643-001	GABAPENTIN	600MG	TABLET / ORAL	AB2	2024-09-09	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203643-001	GABAPENTIN	600MG	TABLET / ORAL	AB2	2024-09-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203643-001	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203643-001	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203643-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203643-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203643-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203643-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203643-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203643-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203643-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203643-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203643-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203643-001	AB2	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203643-001	AB2	1	`a50c72e98297…`

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 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	657349fb-41a9-4814-b4ac-4c5afbdde947	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a15d5dcc-63c4-4c06-ab91-5e22cdf234cc	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	477691f5-0591-4544-840a-ac590e1f25a1	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	506bf880-9564-404c-951a-703797ffdad8	2024-10-29	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	77754734-4125-42b1-97c8-458bcab2bcf1	2024-10-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	fb0b6613-57d6-4e24-946f-f5f87c460cf0	2024-10-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ef37f2a0-3b83-4f71-91c0-6435161b483c	2024-10-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ff28c5f1-da56-4072-a6fa-d689d4a6761b	2024-10-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.