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 10 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	A-S Medication Solutions	aa246838-609c-4254-a8ec-d6f463a17960	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	efb86e22-5a84-4b33-aad0-71dd5a2c6c8f	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	1ead7343-ab25-41b5-af4f-f903470e1dd9	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	781b0d62-a760-4371-8908-1f61329928a6	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	STALLION LABORATORIES PRIVATE LIMITED	b26fd0c6-6aab-4957-8a32-cc7adb9b5fc9	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	American Health Packaging	bbfdedd7-2baf-4bc6-be59-548a5cf21752	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	be9a572d-e98a-41c1-83c5-859d9176dd1c	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	eaf5e41e-8ed3-404e-84e0-392bebdbc0b7	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Proficient Rx LP	da8438e1-755b-4195-baa7-464f3d9ee5bd	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	8f982b95-4e84-4e0c-a543-747bc3dd7531	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d0510d04-460c-47d1-be72-0ee32c4ac640	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	344d67fa-092e-4e71-b96a-25c71bfa6bb1	2025-09-25	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	bc1316b6-1fc4-4990-95a8-489881772876	2025-09-25	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Kesin Pharma Corporation	3f2ba3d6-6086-eaf2-e063-6294a90a7642	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
gabapentin	GABAPENTIN	Coupler LLC	3eeda97d-c3cd-65cd-e063-6394a90aae8b	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
gabapentin	GABAPENTIN	Zydus Lifesciences Limited	8c0eeefc-ef5b-49f4-8411-ddbae312ed05	2025-09-15		Name fallback brand name: gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	MARKSANS PHARMA LIMITED	98bb408d-c402-4da6-8f9d-5de4833dedc4	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Epic Pharma, LLC	d592d828-8df1-480d-b179-bb9260a9c824	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Zydus Pharmaceuticals USA Inc.	310ce005-5a24-489a-b23c-d42ab6a3bfed	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
gabapentin	GABAPENTIN	Zydus Pharmaceuticals USA Inc.	3cfd04ab-e421-441f-a10e-e4dd1412974d	2025-09-05	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.