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 2 of 21 · 402 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	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Trifluent Pharma, LLC	59442de1-7cf0-35f6-e063-6294a90a57d7	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	cb81fd89-b32b-4538-bf5c-ab02f65b3458	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	691205ba-fa65-4bc9-ba20-7d361382cff9	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	97e47698-97c9-4eb5-a108-5850c2aa2818	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	2ac0622c-440a-49a0-974f-726e6ac72a0e	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	48037fc4-1aab-4ae8-aede-7c55b494877a	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	ddb3a54f-5224-4024-8804-b2a2f01d885e	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	fce0c123-29d7-42bf-8c8d-8be1772e2d99	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Redpharm Drug	58474aa7-7c6a-3a94-e063-6394a90a870b	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Coupler LLC	583ab038-7b6e-96f8-e063-6294a90adf47	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	e877a425-2b7f-4e43-a1f9-24019cbf9685	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	TIME CAP LABORATORIES, INC	08880902-bd44-41b6-866b-2cbad4c3f2b1	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	81243958-cc5a-4ec0-a64d-71682f949d5f	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	bc525ae4-9843-4038-a1b7-0d3543e2282c	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	41844c21-9e2a-4332-a8ff-9b71ae9032b0	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	TAGI Pharma, Inc.	725878fa-1e2f-4fee-a9e1-a6e102c79625	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Ascend Laboratories, LLC	722de2a9-38b3-4518-b262-ba0d1346d0ba	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	5a78ab50-993d-4857-be10-be665e02b353	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals, Inc.	57383d2a-d2c7-bbdc-e063-6294a90ada98	2026-07-22	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.