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 14 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afa28969-91ca-83fd-e053-2a95a90a656b	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afa28969-91c8-83fd-e053-2a95a90a656b	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	ADVANCED RX OF TENNESSEE, LLC	af73fbd8-9731-e6bf-e053-2995a90af65d	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afc80b8b-da39-6fb9-e053-2a95a90a2d8e	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b062f12c-a745-76d4-e053-2a95a90a3a1a	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b33c18ea-554d-3cfb-e053-2a95a90a2dd1	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b37b1dcc-c7e9-8845-e053-2995a90a089e	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c898711b-9a65-1816-e053-2995a90a855e	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	d294f6aa-ed82-90a2-e053-2995a90a2896	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	ec1c621b-db2a-1567-e053-2995a90a8695	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c89a68b6-6dc0-4624-e053-2a95a90a687e	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	bc08e35d-ef5d-1dcd-e053-2a95a90ab5de	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	c859e666-d510-426b-e053-2995a90a9a3c	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	ebf57adf-b066-2959-e053-2a95a90a961c	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	ec1a01fe-5531-21df-e053-2a95a90a0561	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	f781d400-7304-5d3e-e053-6294a90ac572	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Camber Pharmaceuticals, Inc.	e8a30eb7-3fc5-456a-bdae-3f4095bf2c2b	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Westminster Pharmaceuticals, LLC	2eec52a1-9016-46dd-8b4c-8dab1d0aeece	2024-12-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Quality Care Products, LLC	ed3a0d48-2e98-44ee-8743-880d1221a480	2024-12-18	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	6e7f602a-2c5f-4651-a228-5fc5bf249205	2024-12-10	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.