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 18 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	e286ed87-5fbc-4ff2-a05e-1f7fa658bbfc	2023-12-20	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	0eb27e64-1488-4083-82c7-cebb8c0605de	2023-12-20	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	ecb798a0-377d-4712-bb82-ec9d7116962f	2023-12-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	40bb60c0-a2f3-4e7f-b13c-028c906c4852	2023-11-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	9c96b488-19bd-431e-af9a-b313ffd9eaae	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	5fb79774-c2d4-47ba-9a16-eb367d0fdcff	2023-09-30	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	af62bb7e-162e-4e2a-8eb0-d50f66678707	2023-09-22	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	77d1d90d-e124-4db7-b811-754d535e579c	2023-09-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	22f2294f-352a-4515-87c8-a6ae46e61322	2023-05-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Exelan Pharmaceuticals Inc.	323dad14-ded9-4432-a265-c957e46cc6db	2023-03-23	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	35004f84-90ae-45f0-a2ba-653dec507229	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Cipla USA Inc.	7c3ac86f-b8f7-42bf-942a-db854d946e54	2023-01-20	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	f7a943ec-9a13-45ba-9bc5-18162b86b921	2023-01-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	20e48004-d8b6-40fd-929b-b95087b4d85d	2022-11-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	c7cb37f9-e1df-4e2a-bde5-9bfa0e040d7a	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	88ac51c4-5fa9-4c35-9c63-f26bcb101d4b	2022-10-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	e89a7ff2-bd82-4fde-b2b7-3b9d0edf6fc8	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	9d544944-ea95-42e1-8c65-9e442437f0ee	2022-10-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	f651a143-3f88-49c9-b5c4-c9af55aea76a	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	176c5b60-93c2-4574-8b51-c15180912aaa	2022-08-01	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.