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 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.

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