Application 022117

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SAPHRIS	ASENAPINE MALEATE	TABLET;SUBLINGUAL	EQ 5MG BASE	Yes	No
002	SAPHRIS	ASENAPINE MALEATE	TABLET;SUBLINGUAL	EQ 10MG BASE	Yes	Yes
003	SAPHRIS	ASENAPINE MALEATE	TABLET;SUBLINGUAL	EQ 2.5MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
N022117-001	SAPHRIS	ASENAPINE MALEATE	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13
N022117-002	SAPHRIS	ASENAPINE MALEATE	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13
N022117-003	SAPHRIS	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022117-001	AB
N022117-002	AB
N022117-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022117-001	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10
N022117-001	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10
N022117-001	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10
N022117-001	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10
N022117-001	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10
N022117-001	8022228	2026-04-06		Drug substance, Drug product	2014-07-29
N022117-001	7741358*PED	2026-10-06		Pediatric extension
N022117-001	8022228*PED	2026-10-06		Pediatric extension
N022117-002	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10
N022117-002	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10
N022117-002	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10
N022117-002	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10
N022117-002	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10
N022117-002	8022228	2026-04-06		Drug substance, Drug product	2014-07-29
N022117-002	7741358*PED	2026-10-06		Pediatric extension
N022117-002	8022228*PED	2026-10-06		Pediatric extension
N022117-003	7741358	2026-04-06	U-1893	Drug substance, Drug product	2016-09-12
N022117-003	7741358	2026-04-06	U-1966	Drug substance, Drug product	2016-09-12
N022117-003	8022228	2026-04-06		Drug substance, Drug product	2016-09-12
N022117-003	7741358*PED	2026-10-06		Pediatric extension
N022117-003	8022228*PED	2026-10-06		Pediatric extension

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022117-002	SAPHRIS	EQ 10MG BASE	TABLET / SUBLINGUAL	AB	RLD, RS	2009-08-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022117-003	SAPHRIS	EQ 2.5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2015-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022117-001	SAPHRIS	EQ 5MG BASE	TABLET / SUBLINGUAL	AB	RLD	2009-08-13	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022117-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022117-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022117-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022117-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022117-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022117-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022117-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022117-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022117-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022117-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022117-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022117-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022117-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022117-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022117-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022117-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022117-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022117-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022117-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022117-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022117-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022117-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022117-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022117-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022117-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022117-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022117-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022117-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022117-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022117-001	AB	1	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 25 · 972 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022117-001	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-001	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-001	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-001	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-001	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-001	8022228	2026-04-06		Drug substance, Drug product	2014-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-001	7741358*PED	2026-10-06		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-001	8022228*PED	2026-10-06		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-002	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-002	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-002	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-002	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-002	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-002	8022228	2026-04-06		Drug substance, Drug product	2014-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-002	7741358*PED	2026-10-06		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-002	8022228*PED	2026-10-06		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-003	7741358	2026-04-06	U-1966	Drug substance, Drug product	2016-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-003	7741358	2026-04-06	U-1893	Drug substance, Drug product	2016-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-003	8022228	2026-04-06		Drug substance, Drug product	2016-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-003	7741358*PED	2026-10-06		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022117-003	8022228*PED	2026-10-06		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022117-001	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	8022228	2026-04-06		Drug substance, Drug product	2014-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	7741358*PED	2026-10-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-001	8022228*PED	2026-10-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	7741358	2026-04-06	U-1963	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	7741358	2026-04-06	U-1064	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	7741358	2026-04-06	U-1961	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	7741358	2026-04-06	U-1960	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	7741358	2026-04-06	U-1962	Drug substance, Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	8022228	2026-04-06		Drug substance, Drug product	2014-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	7741358*PED	2026-10-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-002	8022228*PED	2026-10-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-003	7741358	2026-04-06	U-1966	Drug substance, Drug product	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-003	7741358	2026-04-06	U-1893	Drug substance, Drug product	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022117-003	8022228	2026-04-06		Drug substance, Drug product	2016-09-12	`011fe1cb6892…`

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	N022117-001	D-166	2020-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022117-001	I-597	2020-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022117-002	D-166	2020-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022117-002	I-597	2020-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022117-003	D-166	2020-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022117-003	I-597	2020-01-13	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022117-001	D-166	2020-01-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022117-001	I-597	2020-01-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022117-002	D-166	2020-01-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022117-002	I-597	2020-01-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022117-003	D-166	2020-01-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022117-003	I-597	2020-01-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022117-001	D-166	2020-01-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022117-001	I-597	2020-01-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022117-002	D-166	2020-01-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022117-002	I-597	2020-01-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022117-003	D-166	2020-01-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022117-003	I-597	2020-01-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022117-001	D-166	2020-01-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022117-001	I-597	2020-01-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022117-002	D-166	2020-01-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022117-002	I-597	2020-01-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022117-003	D-166	2020-01-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022117-003	I-597	2020-01-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022117-001	D-166	2020-01-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022117-001	I-597	2020-01-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022117-002	D-166	2020-01-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022117-002	I-597	2020-01-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022117-003	D-166	2020-01-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022117-003	I-597	2020-01-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022117-001	D-166	2020-01-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022117-001	I-597	2020-01-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022117-002	D-166	2020-01-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022117-002	I-597	2020-01-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022117-003	D-166	2020-01-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022117-003	I-597	2020-01-13	`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
SAPHRIS	ASENAPINE MALEATE	Allergan, Inc.	5429f134-839f-4ffc-9944-55f51238def8	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022117 application number: NDA022117 ndc (product): 0456-2410 ndc (product): 0456-2402 ndc (product): 0456-2405

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0052-0118	SAPHRIS	Asenapine Maleate	Organon Pharmaceuticals USA	NDA	Current
0052-0119	SAPHRIS	Asenapine Maleate	Organon Pharmaceuticals USA	NDA	Current
0052-2139	SAPHRIS	Asenapine Maleate	Organon Pharmaceuticals USA	NDA	Current
0052-2142	SAPHRIS	Asenapine Maleate	Organon Pharmaceuticals USA	NDA	Current
0456-2402	SAPHRIS	Asenapine Maleate	Allergan, Inc.	NDA	Current
0456-2402	SAPHRIS	Asenapine Maleate	Allergan, Inc.	NDA	Current
0456-2402	SAPHRIS	Asenapine Maleate	Allergan, Inc.	NDA	Current
0456-2402	SAPHRIS	Asenapine Maleate	Allergan, Inc.	NDA	Current
0456-2405	SAPHRIS	Asenapine Maleate	Allergan, Inc.	NDA	Current
0456-2405	SAPHRIS	Asenapine Maleate	Allergan, Inc.	NDA	Current
0456-2405	SAPHRIS	Asenapine Maleate	Allergan, Inc.	NDA	Current
0456-2405	SAPHRIS	Asenapine Maleate	Allergan, Inc.	NDA	Current
0456-2410	SAPHRIS	Asenapine Maleate	Allergan, Inc.	NDA	Current
0456-2410	SAPHRIS	Asenapine Maleate	Allergan, Inc.	NDA	Current
0456-2410	SAPHRIS	Asenapine Maleate	Allergan, Inc.	NDA	Current
0456-2410	SAPHRIS	Asenapine Maleate	Allergan, Inc.	NDA	Current
59762-1091	Asenapine	asenapine maleate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1091	Asenapine	asenapine maleate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2012	Asenapine	asenapine maleate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2012	Asenapine	asenapine maleate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2888	Asenapine	asenapine maleate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2888	Asenapine	asenapine maleate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81115	SUPPL	2025-02-06
80947	SUPPL	2025-02-05
47405	SUPPL	2017-03-02
47309	SUPPL	2017-02-24
46941	SUPPL	2017-01-24
46940	SUPPL	2017-01-24
46859	SUPPL	2017-01-13
46858	SUPPL	2017-01-13
38282	SUPPL	2015-03-17
38281	SUPPL	2015-03-17
16985	SUPPL	2015-03-17
29288	SUPPL	2015-03-13
29287	SUPPL	2015-03-13
6933	SUPPL	2015-03-13
38280	SUPPL	2014-11-20
16984	SUPPL	2014-11-20
16983	SUPPL	2014-11-20
29286	SUPPL	2014-11-19
29285	SUPPL	2014-11-19
6932	SUPPL	2014-11-19
16980	SUPPL	2014-10-24
6931	SUPPL	2014-10-23
51247	SUPPL	2014-02-06
51246	SUPPL	2014-02-06
51245	SUPPL	2013-08-30
51244	SUPPL	2013-08-30
16981	SUPPL	2013-03-26
29283	SUPPL	2013-03-22
29284	SUPPL	2012-11-09
16982	SUPPL	2012-11-08
44172	ORIG	2011-12-20
29282	SUPPL	2011-10-13
38278	SUPPL	2011-10-12
38279	SUPPL	2011-08-11
6930	SUPPL	2011-08-11
6929	SUPPL	2010-12-07
16979	SUPPL	2010-12-04
51243	SUPPL	2010-10-22
51242	SUPPL	2010-10-22
29281	SUPPL	2010-09-21
6928	SUPPL	2010-09-21
38277	SUPPL	2010-08-30
16978	SUPPL	2010-08-30
51241	SUPPL	2010-06-02
51240	SUPPL	2010-06-02
24244	ORIG	2009-10-02
21939	ORIG	2009-10-02
51239	SUPPL	2009-09-23
51238	SUPPL	2009-09-23
16977	ORIG	2009-08-26
6927	ORIG	2009-08-26
51735	SUPPL	1900-01-01
51733	SUPPL	1900-01-01
51732	SUPPL	1900-01-01
51731	SUPPL	1900-01-01
51727	SUPPL	1900-01-01
51726	SUPPL	1900-01-01