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 1.

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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2004-10-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2004-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075694-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2004-10-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075694-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2004-10-21	`782e0a99824c…`

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 1 of 21 · 410 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	ddb3a54f-5224-4024-8804-b2a2f01d885e	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	fce0c123-29d7-42bf-8c8d-8be1772e2d99	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Redpharm Drug	58474aa7-7c6a-3a94-e063-6394a90a870b	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Coupler LLC	583ab038-7b6e-96f8-e063-6294a90adf47	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	e877a425-2b7f-4e43-a1f9-24019cbf9685	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	TIME CAP LABORATORIES, INC	08880902-bd44-41b6-866b-2cbad4c3f2b1	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	81243958-cc5a-4ec0-a64d-71682f949d5f	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	bc525ae4-9843-4038-a1b7-0d3543e2282c	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Cardinal Health 107, LLC	934244c6-243d-436e-ad6c-f7bd28e45a86	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	TAGI Pharma, Inc.	725878fa-1e2f-4fee-a9e1-a6e102c79625	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Ascend Laboratories, LLC	722de2a9-38b3-4518-b262-ba0d1346d0ba	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	5a78ab50-993d-4857-be10-be665e02b353	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	429a1bb5-babf-4f36-8264-46d71164f1c0	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals, Inc.	57383d2a-d2c7-bbdc-e063-6294a90ada98	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	ScieGen Pharmaceuticals, Inc.	16542ee6-0e0e-4d3c-8b32-60ff6ef48846	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
gabapentin	GABAPENTIN	REMEDYREPACK INC.	32169228-e85c-4dbf-8722-cd2f8e0f5d1a	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	57492b91-1fe2-74ab-e063-6394a90a0b9e	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	07c8bb17-9bd4-4fab-994d-0412205b53b4	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	PD-Rx Pharmaceuticals, Inc.	4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	3c585b71-5cfc-18d6-e063-6294a90a3dcf	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN

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