Application 076017

Type: ANDA
Sponsor: IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	TABLET;ORAL	100MG	No	No
002	GABAPENTIN	GABAPENTIN	TABLET;ORAL	300MG	No	No
003	GABAPENTIN	GABAPENTIN	TABLET;ORAL	400MG	No	No
004	GABAPENTIN	GABAPENTIN	TABLET;ORAL	600MG	No	No
005	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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076017-001	GABAPENTIN	GABAPENTIN	100MG	TABLET / ORAL	AB1	2004-04-28
A076017-002	GABAPENTIN	GABAPENTIN	300MG	TABLET / ORAL		2004-04-28
A076017-003	GABAPENTIN	GABAPENTIN	400MG	TABLET / ORAL	AB1	2004-04-28
A076017-004	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL		2005-04-29
A076017-005	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL		2005-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076017-001	AB1
A076017-003	AB1

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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076017-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2004-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076017-002	GABAPENTIN	300MG	TABLET / ORAL		2004-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076017-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2004-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076017-004	GABAPENTIN	600MG	TABLET / ORAL		2005-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076017-005	GABAPENTIN	800MG	TABLET / ORAL		2005-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076017-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2004-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076017-002	GABAPENTIN	300MG	TABLET / ORAL		2004-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076017-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2004-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076017-004	GABAPENTIN	600MG	TABLET / ORAL		2005-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076017-005	GABAPENTIN	800MG	TABLET / ORAL		2005-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076017-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2004-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076017-002	GABAPENTIN	300MG	TABLET / ORAL		2004-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076017-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2004-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076017-004	GABAPENTIN	600MG	TABLET / ORAL		2005-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076017-005	GABAPENTIN	800MG	TABLET / ORAL		2005-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076017-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2004-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076017-002	GABAPENTIN	300MG	TABLET / ORAL		2004-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076017-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2004-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076017-004	GABAPENTIN	600MG	TABLET / ORAL		2005-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076017-005	GABAPENTIN	800MG	TABLET / ORAL		2005-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076017-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2004-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076017-002	GABAPENTIN	300MG	TABLET / ORAL		2004-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076017-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2004-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076017-004	GABAPENTIN	600MG	TABLET / ORAL		2005-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076017-005	GABAPENTIN	800MG	TABLET / ORAL		2005-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076017-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2004-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076017-002	GABAPENTIN	300MG	TABLET / ORAL	AB1	2004-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076017-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2004-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076017-004	GABAPENTIN	600MG	TABLET / ORAL		2005-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076017-005	GABAPENTIN	800MG	TABLET / ORAL		2005-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076017-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2004-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076017-002	GABAPENTIN	300MG	TABLET / ORAL	AB1	2004-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076017-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2004-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076017-004	GABAPENTIN	600MG	TABLET / ORAL		2005-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076017-005	GABAPENTIN	800MG	TABLET / ORAL		2005-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076017-001	GABAPENTIN	100MG	TABLET / ORAL	AB1	2004-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076017-002	GABAPENTIN	300MG	TABLET / ORAL	AB1	2004-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076017-003	GABAPENTIN	400MG	TABLET / ORAL	AB1	2004-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076017-004	GABAPENTIN	600MG	TABLET / ORAL		2005-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076017-005	GABAPENTIN	800MG	TABLET / ORAL		2005-04-29	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 125 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076017-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076017-003	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076017-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076017-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076017-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076017-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076017-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076017-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076017-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076017-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076017-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076017-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076017-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076017-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076017-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076017-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076017-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076017-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076017-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076017-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076017-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076017-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076017-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076017-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076017-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076017-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076017-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076017-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076017-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076017-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076017-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076017-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076017-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076017-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076017-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076017-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076017-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076017-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076017-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076017-003	AB1	1	`1e350fbaab3a…`

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 12 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Direct_Rx	ed9c501c-24e4-da89-e053-2a95a90a64c6	2025-06-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Preferred Pharmaceuticals Inc.	11645bd6-7cfe-49b2-9292-2e4b0dbb84ae	2025-06-04	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
gabapentin	GABAPENTIN	Rising Pharma Holdings, Inc.	969cccfc-e56a-49da-9d36-47c0c3fad7f8	2025-06-03	Warnings, Adverse reactions	Name fallback brand name: gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	PAI Holdings, LLC dba PAI Pharma	6d3fd1f9-c831-4262-af10-291838a53541	2025-05-31	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Rising Pharma Holdings, Inc.	8215da86-d7af-4980-b6d6-4bd46f6bfeaf	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	ATLANTIC BIOLOGICALS CORP.	5969f1a8-d6d5-4967-add5-4e2492354d7b	2025-05-27	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Camber Pharmaceuticals, Inc.	0ce53f62-1738-43f4-9a2e-c5dc42a91d09	2025-05-26	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	St. Mary's Medical Park Pharmacy	7d3fc163-25f0-2c61-e053-2991aa0a76e9	2025-05-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Granules Pharmaceuticals Inc.	e847bcfa-f3de-404a-8a57-d8a414691e6a	2025-05-14	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Amneal Pharmaceuticals LLC	772d9e7a-3811-455a-99e6-f2a3d0769b9b	2025-05-13	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aurobindo Pharma Limited	1a619a14-0b63-4cba-80e7-474c9a1c90b9	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Aurobindo Pharma Limited	25cf6c40-a239-4dd0-9cad-28da84d285db	2025-05-09	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Proficient Rx LP	3c8dca11-78ab-45c1-8bb2-89a41ea5dfa9	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Exelan Pharmaceuticals, Inc.	41d1ead3-046e-4abf-ae0a-cb126a1f5848	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Actavis Pharma, Inc.	5969871e-6c71-4c37-9d63-370718ccc80c	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Cipla USA Inc.	9e4eca9c-6a2c-4ede-a252-1a27094bf594	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Direct_Rx	30a2ed14-dcda-f972-e063-6294a90a417c	2025-04-23	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
Gabapentin	GABAPENTIN	McKesson Corporation dba Sky Packaging	23eb133e-2f74-4219-9892-0a8e770ec032	2025-04-17	Warnings, Adverse reactions	Name fallback brand name: Gabapentin generic name: GABAPENTIN
GABAPENTIN	GABAPENTIN	Mylan Pharmaceuticals Inc.	cff7de45-148b-4e96-88fd-6052bf75b5f7	2025-04-12	Warnings, Adverse reactions	Name fallback brand name: GABAPENTIN generic name: GABAPENTIN
Gabapentin	GABAPENTIN	Westminster Pharmaceuticals, LLC	3ad96553-73a4-4a9b-8a89-10a29b794ed3	2025-04-04	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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-4443	Gabapentin	Gabapentin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4444	Gabapentin	Gabapentin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50436-7286	Gabapentin	Gabapentin	Unit Dose Services	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8849	ORIG	2004-04-29