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 20 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
GABAPENTIN	GABAPENTIN	Proficient Rx LP	92c4d589-533b-4fe4-833f-dd68cc1f7e66	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	2ef99c3d-866a-438b-a340-8beba8d4c457	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	c78f528f-9192-4037-bfb9-ff5718ed26c5	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Epic Pharma, LLC	030e656a-e384-49ac-830f-32140c18112d	2019-01-07	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	a900bafb-8f49-4a01-ba7f-4fb228ec0253	2018-11-12	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	6702ed8f-4aaf-46fa-bf39-db75154aa44c	2018-10-19	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	1b73e9db-eddb-49ba-9778-01d39ece4d16	2018-09-21	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	f455b415-12a2-4916-b826-246976a8af44	2018-09-12	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	5fbd601f-df95-4a79-a7d3-c3505e23b913	2018-09-06	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	9d1b9121-c25a-4d28-91c5-5fc72f1167f4	2018-07-12		Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	37d4d465-19a5-46db-80dc-0b7334b3343a	2018-06-25	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	6fc8e8b2-5d0e-4c72-9a46-6d312c3efac7	2018-05-14	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