Application 077894

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	TABLET;ORAL	100MG	No	No
002	GABAPENTIN	GABAPENTIN	TABLET;ORAL	300MG	No	No
003	GABAPENTIN	GABAPENTIN	TABLET;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
A077894-001	GABAPENTIN	GABAPENTIN	100MG	TABLET / ORAL	2006-10-10
A077894-002	GABAPENTIN	GABAPENTIN	300MG	TABLET / ORAL	2006-10-10
A077894-003	GABAPENTIN	GABAPENTIN	400MG	TABLET / ORAL	2006-10-10

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 4 · 129 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	A077894-001	GABAPENTIN	100MG	TABLET / ORAL		2006-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077894-002	GABAPENTIN	300MG	TABLET / ORAL		2006-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077894-003	GABAPENTIN	400MG	TABLET / ORAL		2006-10-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077894-001	GABAPENTIN	100MG	TABLET / ORAL		2006-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077894-002	GABAPENTIN	300MG	TABLET / ORAL		2006-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077894-003	GABAPENTIN	400MG	TABLET / ORAL		2006-10-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077894-001	GABAPENTIN	100MG	TABLET / ORAL		2006-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077894-002	GABAPENTIN	300MG	TABLET / ORAL		2006-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077894-003	GABAPENTIN	400MG	TABLET / ORAL		2006-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077894-001	GABAPENTIN	100MG	TABLET / ORAL		2006-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077894-002	GABAPENTIN	300MG	TABLET / ORAL		2006-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077894-003	GABAPENTIN	400MG	TABLET / ORAL		2006-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077894-001	GABAPENTIN	100MG	TABLET / ORAL		2006-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077894-002	GABAPENTIN	300MG	TABLET / ORAL		2006-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077894-003	GABAPENTIN	400MG	TABLET / ORAL		2006-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077894-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2006-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077894-002	GABAPENTIN	300MG	TABLET / ORAL	AB1	2006-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077894-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2006-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077894-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2006-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077894-002	GABAPENTIN	300MG	TABLET / ORAL	AB1	2006-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077894-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2006-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077894-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2006-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077894-002	GABAPENTIN	300MG	TABLET / ORAL	AB1	2006-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077894-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2006-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077894-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2006-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077894-002	GABAPENTIN	300MG	TABLET / ORAL	AB1	2006-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077894-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2006-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077894-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2006-10-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077894-002	GABAPENTIN	300MG	TABLET / ORAL	AB1	2006-10-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077894-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2006-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077894-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2006-10-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077894-002	GABAPENTIN	300MG	TABLET / ORAL	AB1	2006-10-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077894-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2006-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077894-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2006-10-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077894-002	GABAPENTIN	300MG	TABLET / ORAL	AB1	2006-10-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077894-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2006-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077894-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2006-10-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077894-002	GABAPENTIN	300MG	TABLET / ORAL	AB1	2006-10-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077894-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2006-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077894-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2006-10-10	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077894-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077894-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077894-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077894-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077894-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077894-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077894-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077894-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077894-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077894-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077894-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077894-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077894-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077894-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077894-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077894-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077894-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077894-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077894-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077894-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077894-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077894-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077894-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077894-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077894-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077894-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077894-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077894-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077894-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077894-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077894-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077894-002	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077894-003	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077894-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077894-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077894-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077894-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077894-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077894-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077894-001	AB	1	`4b0b4de00fa7…`

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 20 · 394 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Neurontin	GABAPENTIN	Parke-Davis Div of Pfizer Inc	ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388	2022-07-12	Warnings, Adverse reactions	Name fallback generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	14b1840d-a2db-4eec-bc25-029e35b042e4	2022-07-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	c18d9d06-f796-4eb7-8fd5-1de4ebb95439	2022-07-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	17988b64-723c-488d-befd-3e4e4cc44bd2	2022-05-11	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	ed22b78e-93ff-4cb5-9c9c-2afe9b60dd2e	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	645824d0-eb3d-442b-806d-36a70796cb8e	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Proficient Rx LP	aa3ab216-372a-4a72-bfd1-88a1ffa31ba3	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	b67b7865-df64-429a-9550-5333b9c713ea	2022-04-01	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-2548	Gabapentin	Gabapentin	Apotex Corp.	ANDA	Current
60505-2549	Gabapentin	Gabapentin	Apotex Corp.	ANDA	Current
60505-2550	Gabapentin	Gabapentin	Apotex Corp.	ANDA	Current