Application 075827

Type: ANDA
Sponsor: TEVA

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
A075827-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL			2004-12-15
A075827-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL			2004-12-15

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075827-001	GABAPENTIN	600MG	TABLET / ORAL	2004-12-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075827-002	GABAPENTIN	800MG	TABLET / ORAL	2004-12-15	`74a2ff9319b5…`

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 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	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
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	39149f0e-30ed-4671-8be7-2a484f65d63b	2020-08-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	ded42b88-94dd-462d-bcdf-7fd34d1e49c3	2020-07-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Asclemed USA, Inc.	45039bba-7a96-450c-95be-83a3aa4fcbd2	2020-06-10	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	8b2f38ef-0a0c-45cc-88ca-cc086bf80641	2020-06-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	ba2a8352-5776-4edb-914e-ce1d18ccda32	2020-05-27	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	c09c66fd-cb31-41dd-b00b-acc58bd809f7	2020-01-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	7d77dae0-df76-4b7b-9690-713e9a60e3cd	2019-12-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Proficient Rx LP	4bae5032-f634-4d1e-b672-8a7e2bd6a5fa	2019-11-01	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.