Application 208928

Type: ANDA
Sponsor: IPCA LABS LTD

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	Approval date
A208928-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	2023-11-20
A208928-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	2023-11-20
A208928-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	2023-11-20

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 2 · 60 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	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL		2023-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208928-002	GABAPENTIN	300MG	CAPSULE / ORAL		2023-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208928-003	GABAPENTIN	400MG	CAPSULE / ORAL		2023-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL		2023-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208928-002	GABAPENTIN	300MG	CAPSULE / ORAL		2023-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208928-003	GABAPENTIN	400MG	CAPSULE / ORAL		2023-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL		2023-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208928-002	GABAPENTIN	300MG	CAPSULE / ORAL		2023-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208928-003	GABAPENTIN	400MG	CAPSULE / ORAL		2023-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL		2023-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208928-002	GABAPENTIN	300MG	CAPSULE / ORAL		2023-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208928-003	GABAPENTIN	400MG	CAPSULE / ORAL		2023-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL		2023-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208928-002	GABAPENTIN	300MG	CAPSULE / ORAL		2023-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208928-003	GABAPENTIN	400MG	CAPSULE / ORAL		2023-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL		2023-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208928-002	GABAPENTIN	300MG	CAPSULE / ORAL		2023-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208928-003	GABAPENTIN	400MG	CAPSULE / ORAL		2023-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL		2023-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208928-002	GABAPENTIN	300MG	CAPSULE / ORAL		2023-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208928-003	GABAPENTIN	400MG	CAPSULE / ORAL		2023-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL		2023-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208928-002	GABAPENTIN	300MG	CAPSULE / ORAL		2023-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208928-003	GABAPENTIN	400MG	CAPSULE / ORAL		2023-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2023-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208928-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2023-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208928-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2023-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2023-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208928-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2023-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208928-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2023-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2023-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208928-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2023-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208928-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2023-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2023-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208928-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2023-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208928-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2023-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2023-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208928-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2023-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208928-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2023-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208928-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2023-11-20	`301d65b070ca…`

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	A208928-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208928-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208928-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208928-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208928-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208928-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208928-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208928-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208928-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208928-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208928-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208928-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208928-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208928-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208928-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208928-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208928-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208928-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208928-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208928-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208928-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208928-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208928-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208928-003	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208928-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208928-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208928-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208928-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208928-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208928-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208928-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208928-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208928-003	AB	1	`ea1830bbd6c7…`

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 15 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c859e666-d510-426b-e053-2995a90a9a3c	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	ebf57adf-b066-2959-e053-2a95a90a961c	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	ec1a01fe-5531-21df-e053-2a95a90a0561	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	f781d400-7304-5d3e-e053-6294a90ac572	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Camber Pharmaceuticals, Inc.	e8a30eb7-3fc5-456a-bdae-3f4095bf2c2b	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Westminster Pharmaceuticals, LLC	2eec52a1-9016-46dd-8b4c-8dab1d0aeece	2024-12-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Quality Care Products, LLC	ed3a0d48-2e98-44ee-8743-880d1221a480	2024-12-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	6e7f602a-2c5f-4651-a228-5fc5bf249205	2024-12-10	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	1fd95278-842f-4bf9-abd5-4d9aa858d36d	2024-12-10	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	97a1d45d-d5b3-4be7-9b3a-cb6f80f60291	2024-12-09	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	481e6b68-50e4-4594-9815-32580a84ab8c	2024-12-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Zydus Lifesciences Limited	b033c169-4943-4ad9-ace0-7e4a1f0dc100	2024-11-30		Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	17a62334-209d-4dc1-867a-e5780196a2ca	2024-11-05	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals,Inc.	a072d5d2-8c75-59cc-e053-2a95a90ac0cc	2024-11-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	7b404ab9-8a7e-49d4-920f-487875d14e45	2024-11-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	c33c4d83-cc13-4104-9e24-d4cd40b17b70	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	e2d9bd8c-3bb9-4945-8e61-7d2703d9008c	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	5769d849-4f27-4701-97ec-7e3ca07339d7	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Westminster Pharmaceuticals, LLC	2f70c496-b58c-30f5-e054-00144ff8d46c	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	78088f6a-06a3-422f-b336-4a57a24adc16	2024-10-30	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.