Application 075435

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	100MG	No	No
002	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	300MG	No	No
003	GABAPENTIN	GABAPENTIN	CAPSULE;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A075435-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08
A075435-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08
A075435-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08

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 4 · 129 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	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075435-002	GABAPENTIN	300MG	CAPSULE / ORAL	2004-10-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075435-003	GABAPENTIN	400MG	CAPSULE / ORAL	2004-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075435-001	GABAPENTIN	100MG	CAPSULE / ORAL	2004-10-08	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075435-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075435-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075435-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075435-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075435-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075435-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075435-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075435-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075435-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075435-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075435-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075435-003	AB	1	`ea99ee380514…`

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 8 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GABAPENTIN	GABAPENTIN	REMEDYREPACK INC.	915cee37-536c-4761-bdb9-b96c7ee0f956	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	09736975-2493-4dbc-bbe0-cc56a1fec53f	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	c979f80b-d4b1-40f7-b878-b216db5f325d	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	b88b0cbc-c883-4d17-8f46-0e5bddc57835	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	3dbd447f-4791-4c62-86b4-6f7928862785	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	081fd1de-acaa-4685-a053-4959d77b17e9	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	2343e3a1-82d0-4c70-a086-a01a0ce81ef3	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	A-S Medication Solutions	67330eef-c976-4862-b1ae-20f30f43df76	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	2e331641-ec26-4d76-b16b-a9863c767afe	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	cc1998a7-7004-4688-8b5b-525041851d1d	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	4aa69d04-6b32-4764-a48b-ef5313dd95d3	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	60b46f6d-efbc-487a-b672-b20df8b44cc4	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	43a3ec78-8235-4d46-a343-2f9226745a39	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	685553b0-384e-400b-a8ae-612ceece8261	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	A-S Medication Solutions	7ea0b220-edbb-45eb-aeb3-65283f8489a1	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Preferred Pharmaceuticals, Inc.	bff3beea-1f05-4e84-bcd2-d05782acddae	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	DIRECT RX	29a70e2d-d3fd-4e32-95dd-7ee721d87388	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
gabapentin	GABAPENTIN	Coupler LLC	47cd25f6-e123-9aaf-e063-6394a90aeedd	2026-01-07	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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66116-444	Gabapentin	Gabapentin	MedVantx Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8669	ORIG	2004-10-08