Application 206402

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABAPENTIN	GABAPENTIN	TABLET;ORAL	600MG	No	No
002	GABAPENTIN	GABAPENTIN	TABLET;ORAL	800MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206402-001	GABAPENTIN	GABAPENTIN	600MG	TABLET / ORAL	AB1		2015-12-23
A206402-002	GABAPENTIN	GABAPENTIN	800MG	TABLET / ORAL	AB1		2015-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206402-001	AB1
A206402-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB1	2015-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB1	2015-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2015-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2015-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2015-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2015-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2015-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2015-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2015-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2015-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2015-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2015-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206402-001	GABAPENTIN	600MG	TABLET / ORAL	AB	2015-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206402-002	GABAPENTIN	800MG	TABLET / ORAL	AB	2015-12-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206402-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206402-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206402-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206402-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206402-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206402-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206402-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206402-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206402-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206402-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206402-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206402-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206402-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206402-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206402-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206402-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206402-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206402-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206402-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206402-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206402-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206402-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206402-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206402-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206402-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206402-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206402-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206402-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206402-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206402-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206402-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206402-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206402-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206402-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206402-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206402-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206402-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206402-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206402-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206402-002	AB	1	`782e0a99824c…`

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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	81243958-cc5a-4ec0-a64d-71682f949d5f	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402 ndc (product): 70518-2842
Gabapentin	GABAPENTIN	REMEDYREPACK INC.	bc525ae4-9843-4038-a1b7-0d3543e2282c	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402 ndc (product): 70518-2912
Gabapentin	GABAPENTIN	NuCare Pharmaceuticals, Inc.	57383d2a-d2c7-bbdc-e063-6294a90ada98	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	172776c0-909e-49ce-bfe1-cf154a9458ba	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402 ndc (product): 71335-2038
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	df9c7c84-a8d9-4da8-babe-c55c9420d4e6	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402 ndc (product): 71335-2048
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	72729513-bd34-44f5-9f62-297ed25c4442	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	f31172a2-0ae9-49f2-b797-b26fe33f3f64	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402 ndc (product): 71335-2037
Gabapentin	GABAPENTIN	Ascend Laboratories, LLC	4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402 ndc (product): 67877-429 ndc (product): 67877-428
Gabapentin	GABAPENTIN	Direct_Rx	30a2ed14-dcda-f972-e063-6294a90a417c	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402
Gabapentin	GABAPENTIN	Bryant Ranch Prepack	a1ff94a9-69c4-486a-aab2-563c7ed244c8	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402 ndc (product): 71335-1200
Gabapentin	GABAPENTIN	Advanced Rx of Tennessee, LLC	afa28969-91ca-83fd-e053-2a95a90a656b	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206402 application number: ANDA206402 ndc (product): 80425-0035

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2539	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50090-2539	Gabapentin	Gabapentin	A-S Medication Solutions	ANDA	Current
50436-0428	Gabapentin	Gabapentin	Unit Dose Services	ANDA	Current
50436-4290	Gabapentin	Gabapentin	Unit Dose Services	ANDA	Current
63629-8060	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
63629-8060	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
67877-428	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
67877-428	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
67877-428	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
67877-428	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
67877-428	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
67877-428	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
67877-428	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
67877-429	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
67877-429	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
67877-429	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
67877-429	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
67877-429	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
67877-429	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
67877-429	Gabapentin	Gabapentin	Ascend Laboratories, LLC	ANDA	Current
70518-2842	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-2842	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-2842	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70518-2912	Gabapentin	Gabapentin	REMEDYREPACK INC.	ANDA	Current
70934-933	Gabapentin	Gabapentin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-950	Gabapentin	Gabapentin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1200	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1200	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1200	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-1200	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-2037	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-2037	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-2038	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-2038	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-2048	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-2048	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
71335-2048	Gabapentin	Gabapentin	Bryant Ranch Prepack	ANDA	Current
80425-0035	Neurontin	Gabapentin 800mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0035	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0035	Gabapentin	Gabapentin	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current