Application 022399

Type: NDA
Sponsor: ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HORIZANT	GABAPENTIN ENACARBIL	TABLET, EXTENDED RELEASE;ORAL	600MG	Yes	Yes
002	HORIZANT	GABAPENTIN ENACARBIL	TABLET, EXTENDED RELEASE;ORAL	300MG	Yes	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
N022399-001	HORIZANT	GABAPENTIN ENACARBIL	600MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2011-04-06
N022399-002	HORIZANT	GABAPENTIN ENACARBIL	300MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2011-12-13

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022399-001	8114909	2026-04-11	U-1231		2012-03-13
N022399-001	8026279	2026-11-10		Drug substance, Drug product	2011-10-24
N022399-001	8795725	2029-06-10	U-1231	Drug product	2014-08-27
N022399-001	8795725	2029-06-10	U-1247	Drug product	2014-08-27
N022399-002	8114909	2026-04-11	U-1231
N022399-002	8026279	2026-11-10		Drug substance, Drug product	2012-01-05
N022399-002	8795725	2029-06-10	U-1231	Drug product	2014-08-27
N022399-002	8795725	2029-06-10	U-1247	Drug product	2014-08-27

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022399-001	HORIZANT	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022399-002	HORIZANT	300MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-12-13	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 598 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022399-001	8114909	2026-04-11	U-1231		2012-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-001	8026279	2026-11-10		Drug substance, Drug product	2011-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-001	8795725	2029-06-10	U-1231	Drug product	2014-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-001	8795725	2029-06-10	U-1247	Drug product	2014-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-002	8114909	2026-04-11	U-1231			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-002	8026279	2026-11-10		Drug substance, Drug product	2012-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-002	8795725	2029-06-10	U-1231	Drug product	2014-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022399-002	8795725	2029-06-10	U-1247	Drug product	2014-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	8686034	2025-01-24	U-1247		2014-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	8686034	2025-01-24	U-1231		2014-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	6818787	2025-04-06		Drug substance, Drug product	2011-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	8114909	2026-04-11	U-1231		2012-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	8026279	2026-11-10		Drug substance, Drug product	2011-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	8795725	2029-06-10	U-1231	Drug product	2014-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-001	8795725	2029-06-10	U-1247	Drug product	2014-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	8686034	2025-01-24	U-1231		2014-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	8686034	2025-01-24	U-1247		2014-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	6818787	2025-04-06		Drug substance, Drug product	2012-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	8114909	2026-04-11	U-1231			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	8026279	2026-11-10		Drug substance, Drug product	2012-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	8795725	2029-06-10	U-1231	Drug product	2014-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022399-002	8795725	2029-06-10	U-1247	Drug product	2014-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022399-001	8686034	2025-01-24	U-1247		2014-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-001	8686034	2025-01-24	U-1231		2014-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-001	6818787	2025-04-06		Drug substance, Drug product	2011-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-001	8114909	2026-04-11	U-1231		2012-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-001	8026279	2026-11-10		Drug substance, Drug product	2011-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-001	8795725	2029-06-10	U-1231	Drug product	2014-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-001	8795725	2029-06-10	U-1247	Drug product	2014-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	8686034	2025-01-24	U-1231		2014-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	8686034	2025-01-24	U-1247		2014-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	6818787	2025-04-06		Drug substance, Drug product	2012-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	8114909	2026-04-11	U-1231			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	8026279	2026-11-10		Drug substance, Drug product	2012-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	8795725	2029-06-10	U-1231	Drug product	2014-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022399-002	8795725	2029-06-10	U-1247	Drug product	2014-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022399-001	8686034	2025-01-24	U-1247		2014-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022399-001	8686034	2025-01-24	U-1231		2014-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022399-001	6818787	2025-04-06		Drug substance, Drug product	2011-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022399-001	8114909	2026-04-11	U-1231		2012-03-13	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022399-001	ODE-25	2019-06-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022399-002	ODE-25	2019-06-06	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022399-001	ODE-25	2019-06-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022399-002	ODE-25	2019-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022399-001	ODE-25	2019-06-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022399-002	ODE-25	2019-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022399-001	ODE-25	2019-06-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022399-002	ODE-25	2019-06-06	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Horizant	GABAPENTIN ENACARBIL	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	4c486fc7-c8c4-4c6c-b30c-366dabaeaadd	2025-04-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022399 application number: NDA022399 ndc (product): 53451-0101 ndc (product): 53451-0103

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53451-0101	Horizant	gabapentin enacarbil	Arbor Pharmaceuticals	NDA	Current
53451-0101	Horizant	gabapentin enacarbil	Arbor Pharmaceuticals	NDA	Current
53451-0101	Horizant	gabapentin enacarbil	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	NDA	Current
53451-0101	Horizant	gabapentin enacarbil	Arbor Pharmaceuticals	NDA	Current
53451-0101	Horizant	gabapentin enacarbil	Arbor Pharmaceuticals	NDA	Current
53451-0103	Horizant	gabapentin enacarbil	Arbor Pharmaceuticals	NDA	Current
53451-0103	Horizant	gabapentin enacarbil	Arbor Pharmaceuticals	NDA	Current
53451-0103	Horizant	gabapentin enacarbil	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	NDA	Current
53451-0103	Horizant	gabapentin enacarbil	Arbor Pharmaceuticals	NDA	Current
53451-0103	Horizant	gabapentin enacarbil	Arbor Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82107	SUPPL	2025-05-01
82056	SUPPL	2025-04-29
82055	SUPPL	2025-04-25
62612	SUPPL	2020-04-20
62611	SUPPL	2020-04-20
62596	SUPPL	2020-04-20
62529	SUPPL	2020-04-10
62429	SUPPL	2020-04-03
60742	SUPPL	2019-10-31
45791	SUPPL	2016-11-02
17313	SUPPL	2013-05-09
29677	SUPPL	2013-05-07
38654	SUPPL	2013-04-01
7323	SUPPL	2013-03-29
38656	SUPPL	2012-12-28
38655	SUPPL	2012-12-28
29676	SUPPL	2012-12-27
7324	SUPPL	2012-12-27
17311	SUPPL	2012-06-11
29675	SUPPL	2012-06-08
7322	SUPPL	2012-04-23
17312	SUPPL	2012-04-20
44747	ORIG	2011-05-16
22011	ORIG	2011-05-16
7321	ORIG	2011-04-11
38653	ORIG	2011-04-07
23392	ORIG	2011-04-07