Application 078787

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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	TE codes	Approval date
A078787-001	GABAPENTIN	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31
A078787-002	GABAPENTIN	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31
A078787-003	GABAPENTIN	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078787-001	AB
A078787-002	AB
A078787-003	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-002	GABAPENTIN	300MG	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-003	GABAPENTIN	400MG	CAPSULE / ORAL	AB	2008-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-001	GABAPENTIN	100MG	CAPSULE / ORAL	AB	2008-01-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A078787-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078787-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078787-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078787-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078787-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078787-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078787-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078787-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078787-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078787-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078787-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078787-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078787-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078787-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078787-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078787-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078787-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078787-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078787-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078787-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078787-001	AB	1	`301d65b070ca…`

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 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	Redpharm Drug	58474aa7-7c6a-3a94-e063-6394a90a870b	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	6beed8eb-446c-4575-8dc8-b798623d92c7	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787 ndc (product): 70518-2911
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	912d8697-b466-48dc-88d3-d2ba90e76644	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787 ndc (product): 71335-1484
Gabapentin	GABAPENTIN	A-S Medication Solutions	3dbd447f-4791-4c62-86b4-6f7928862785	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	67330eef-c976-4862-b1ae-20f30f43df76	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	efb86e22-5a84-4b33-aad0-71dd5a2c6c8f	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	eaf5e41e-8ed3-404e-84e0-392bebdbc0b7	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	344d67fa-092e-4e71-b96a-25c71bfa6bb1	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	bc1316b6-1fc4-4990-95a8-489881772876	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	NorthStar Rx LLC	f7c1fd34-d615-43a2-8989-898fe11f90df	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	d25daaac-a8ab-4f12-acc2-4ec8fc97a2d4	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Aurobindo Pharma Limited	1a619a14-0b63-4cba-80e7-474c9a1c90b9	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787 ndc (product): 65862-200
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	b33c18ea-554d-3cfb-e053-2a95a90a2dd1	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787 ndc (product): 80425-0082
Gabapentin	GABAPENTIN	Advanced Rx Pharmacy of Tennessee, LLC	bc08e35d-ef5d-1dcd-e053-2a95a90ab5de	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787 ndc (product): 80425-0128
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	ff28c5f1-da56-4072-a6fa-d689d4a6761b	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787 ndc (product): 71335-1655
Gabapentin	GABAPENTIN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1e28ad3d-2d34-a5d0-e063-6294a90adb9e	2024-07-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	A-S Medication Solutions	ecb798a0-377d-4712-bb82-ec9d7116962f	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787
Gabapentin	GABAPENTIN	Aphena Pharma Solutions - Tennessee, LLC	3b4395f2-9440-4b67-97cc-5d16f3bdd05e	2020-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787 ndc (product): 71610-188
Gabapentin	GABAPENTIN	Proficient Rx LP	ded42b88-94dd-462d-bcdf-7fd34d1e49c3	2020-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787 ndc (product): 71205-295
Gabapentin	GABAPENTIN	Proficient Rx LP	7d77dae0-df76-4b7b-9690-713e9a60e3cd	2019-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078787 application number: ANDA078787 ndc (product): 71205-373

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 2 of 2 · 111 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65862-200	Gabapentin	Gabapentin	Aurobindo Pharma Limited	ANDA	Current
65862-200	Gabapentin	Gabapentin	Aurobindo Pharma Limited	ANDA	Current
66116-407	Gabapentin	Gabapentin	MedVantx, Inc.	ANDA	Current
68071-2907	Gabapentin	Gabapentin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1544	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-1544	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-2911	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-2911	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
71205-295	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
71205-295	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
71205-295	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
71205-295	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
71205-373	Gabapentin	Gabapentin	Proficient Rx LP	ANDA	Current
71335-1484	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1484	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1655	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1655	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71610-126	Gabapentin	Gabapentin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-188	Gabapentin	Gabapentin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-188	Gabapentin	Gabapentin	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
80175-0662	Gabapentin	Gabapentin	Central Packaging	ANDA	Current
80175-0662	Gabapentin	Gabapentin	Central Packaging	ANDA	Current
80425-0082	Neurontin	Gabapentin 400mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0082	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0082	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0082	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0128	Neurontin	Gabapentin 100mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0128	Neurontin	Gabapentin 100mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0128	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0128	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0128	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23919	ORIG	2008-02-28