Application 209855

Type: ANDA
Sponsor: IPCA LABS LTD

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
A209855-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL			2024-05-29
A209855-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL			2024-05-29

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	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209855-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2024-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209855-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2024-05-29	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209855-001	GABAPENTIN	600MG	TABLET / ORAL		2024-05-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209855-002	GABAPENTIN	800MG	TABLET / ORAL		2024-05-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209855-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209855-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209855-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209855-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209855-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209855-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209855-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209855-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209855-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209855-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209855-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209855-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209855-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209855-002	AB1	1	`1e350fbaab3a…`

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 5 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	4c49d34d-bb47-406b-8f2d-b4834b2ee9d0	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Coupler LLC	5385e27c-f2fa-32d5-e063-6294a90a0a8c	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Ascend Laboratories, LLC	4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	St. Mary's Medical Park Pharmacy	07f07d15-ee91-8c2a-e063-6394a90a4624	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	b2da7d96-73ad-4f44-8784-160a384a0961	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	f93eaa4f-cc1a-10ab-e053-6394a90a5ffc	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Direct_Rx	f8998c1c-c359-6f01-e053-6294a90aebf4	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
gabapentin	GABAPENTIN	Proficient Rx LP	c7674ea5-276b-4bb3-821b-4ac05c9e64e6	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Amneal Pharmaceuticals LLC	507bf6d0-e7a2-413d-9848-cd2445a1411d	2026-05-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Laurus Labs Limited	07aa1bcc-df05-44fa-92d4-63894e0e6cd6	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	03031adf-d36b-45ec-944e-dfce5a5de91a	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Pangea Pharmaceuticals, LLC	5eff7ad8-0d31-4372-82a2-ac9f549d8796	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	397fd6d3-317b-4b61-a52b-3a09ca1d88a4	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	13640281-26b4-402e-8f69-7c81cd6e0376	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Amici Pharma, Inc.	1ea83c18-7107-41f4-8305-62725c1c45c8	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	d4f21e97-5e55-44c9-9b31-5f79ac2eb512	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Neurontin	GABAPENTIN	Viatris Specialty LLC	97935fd9-1d4a-43b6-a5d9-de994591187b	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	eeb19a5a-b31d-4df8-9546-0b2b5eb5db07	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Major Pharmaceuticals	152adf1d-ec0c-4561-bf80-e4c7da158723	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Major Pharmaceuticals	999f3685-2eac-467e-bed2-1d0c36aaf0ed	2026-05-04	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.