Application 075694

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

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
A075694-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL			2004-10-21
A075694-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL			2004-10-21

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 3 · 86 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	A075694-001	GABAPENTIN	600MG	TABLET / ORAL		2004-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075694-002	GABAPENTIN	800MG	TABLET / ORAL		2004-10-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075694-001	GABAPENTIN	600MG	TABLET / ORAL		2004-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075694-002	GABAPENTIN	800MG	TABLET / ORAL		2004-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075694-001	GABAPENTIN	600MG	TABLET / ORAL		2004-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075694-002	GABAPENTIN	800MG	TABLET / ORAL		2004-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075694-001	GABAPENTIN	600MG	TABLET / ORAL		2004-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075694-002	GABAPENTIN	800MG	TABLET / ORAL		2004-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075694-001	GABAPENTIN	600MG	TABLET / ORAL		2004-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075694-002	GABAPENTIN	800MG	TABLET / ORAL		2004-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2004-10-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2004-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2004-10-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2004-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2004-10-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2004-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2004-10-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2004-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2004-10-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2004-10-21	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A075694-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075694-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075694-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075694-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075694-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075694-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075694-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075694-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075694-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075694-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075694-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075694-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075694-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075694-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075694-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075694-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075694-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075694-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075694-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075694-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075694-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075694-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075694-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075694-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075694-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075694-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075694-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075694-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075694-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075694-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075694-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075694-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075694-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075694-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075694-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075694-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075694-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075694-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075694-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075694-002	AB	1	`8869cabd3fbd…`

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 19 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Gabapentin	GABAPENTIN	Proficient Rx LP	223a9216-6e07-49b9-8faf-bb4e529a6ae5	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	2fb2233f-9152-4630-ab39-51a0cda7e5ca	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	52af51ab-6543-466b-848c-13c588c98789	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	2b76955c-52a4-4026-b286-3da1112fe989	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	7790d906-af26-4e60-bc6f-e906ec03cc24	2022-03-21	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	7f579665-afb7-4227-98c1-2eafee650504	2022-02-28	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Proficient Rx LP	185f264e-db32-41cd-b90d-519717b97850	2021-11-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Amneal Pharmaceuticals of New York LLC	b11dbff5-ceee-4a63-a093-f6efebdc2f6f	2021-02-03	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	f6baeb5c-ca9c-4730-aeb8-8f8732e8ca3a	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	c79d94ec-117d-4fb6-845d-1954e3472bb0	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gaba 300-EZS	GABAPENTIN	PureTek Corporation	bb29692e-1546-4d05-a46a-93baf4172c7d	2020-11-16	Warnings, Adverse reactions	Name fallback generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	3b4395f2-9440-4b67-97cc-5d16f3bdd05e	2020-08-14	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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-2636	Gabapentin	Gabapentin	Actavis Pharma, Inc.	ANDA	Current
0228-2636	Gabapentin	Gabapentin	Actavis Pharma, Inc.	ANDA	Current
0228-2636	Gabapentin	Gabapentin	Actavis Pharma, Inc.	ANDA	Current
0228-2636	Gabapentin	Gabapentin	Actavis Pharma, Inc.	ANDA	Current
0228-2636	Gabapentin	Gabapentin	Actavis Pharma, Inc.	ANDA	Current
0228-2636	Gabapentin	Gabapentin	Actavis Pharma, Inc.	ANDA	Current
0228-2637	Gabapentin	Gabapentin	Actavis Pharma, Inc.	ANDA	Current
0228-2637	Gabapentin	Gabapentin	Actavis Pharma, Inc.	ANDA	Current
0228-2637	Gabapentin	Gabapentin	Actavis Pharma, Inc.	ANDA	Current
0228-2637	Gabapentin	Gabapentin	Actavis Pharma, Inc.	ANDA	Current
0228-2637	Gabapentin	Gabapentin	Actavis Pharma, Inc.	ANDA	Current
0228-2637	Gabapentin	Gabapentin	Actavis Pharma, Inc.	ANDA	Current
0615-6548	Gabapentin	Gabapentin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-6554	Gabapentin	Gabapentin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6586	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
0904-6586	Gabapentin	Gabapentin	Major Pharmaceuticals	ANDA	Current
55154-7989	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
55154-7989	Gabapentin	Gabapentin	Cardinal Health	ANDA	Current
63187-006	Gabapentin	Gabapentin	Proficient Rx	ANDA	Current
63187-006	Gabapentin	Gabapentin	Proficient Rx	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24154	ORIG	2008-02-01