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 19 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neurontin	GABAPENTIN	Parke-Davis Div of Pfizer Inc	ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388	2022-07-12	Warnings, Adverse reactions	Name fallback generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	14b1840d-a2db-4eec-bc25-029e35b042e4	2022-07-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	c18d9d06-f796-4eb7-8fd5-1de4ebb95439	2022-07-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	17988b64-723c-488d-befd-3e4e4cc44bd2	2022-05-11	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	ed22b78e-93ff-4cb5-9c9c-2afe9b60dd2e	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	645824d0-eb3d-442b-806d-36a70796cb8e	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Proficient Rx LP	aa3ab216-372a-4a72-bfd1-88a1ffa31ba3	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	b67b7865-df64-429a-9550-5333b9c713ea	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
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

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