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 4 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Proficient Rx LP	9d401e54-d4f5-43ba-b898-dd08fc3c7bfa	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gralise	GABAPENTIN	Almatica Pharma LLC	466273b1-c9fc-3930-c94b-aa11394d5140	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: GABAPENTIN
Gabapentin	GABAPENTIN	HAWAII REPACK, INC.	14d61caa-17ce-4fa2-90fb-1470f3864be8	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	2bc65375-77b8-1e50-e063-6294a90acf8f	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	ba4d863d-be38-8cf5-e053-2995a90a69fb	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	c85ae572-9893-629e-e053-2995a90a23fc	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Zhejiang Yongtai Pharmaceutical Co., Ltd	f1eda6cc-d9b2-4df4-a09b-20eebded760f	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	552912b2-be59-0333-e063-6394a90a85c0	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	55292235-bf8f-46d0-e063-6294a90a91a5	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54ecc64b-f019-9fcb-e063-6294a90a00af	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54edd6f3-06c7-a0c7-e063-6394a90a8b4f	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Teva Pharmaceuticals, Inc.	c7f21eaa-68ee-420c-9c98-e997cc73a297	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Northwind Health Company, LLC	1b44a3ab-4d06-205f-e063-6294a90af368	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Unit Dose Solutions, Inc.	54dc347e-cba0-ea73-e063-6294a90ab436	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	St. Mary's Medical Park Pharmacy	235a6954-318a-9e3a-e063-6394a90a0e21	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Bryant Ranch Prepack	c9f0cceb-b24e-4526-b873-fedd877d6bc6	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Granules Pharmaceuticals Inc	c681c804-c6f3-d63b-e053-2995a90a6b8f	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Asclemed USA, Inc.	9a829dc3-b2d8-4d19-a579-0597217cec9b	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	d8604417-9d43-4d27-a7ce-d4120ff201f4	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	b7a29b99-ce23-950e-e053-2995a90a1934	2026-06-09	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