Application 022192

Type: NDA
Sponsor: VANDA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FANAPT	ILOPERIDONE	TABLET;ORAL	1MG	Yes	Yes
002	FANAPT	ILOPERIDONE	TABLET;ORAL	2MG	Yes	No
003	FANAPT	ILOPERIDONE	TABLET;ORAL	4MG	Yes	No
004	FANAPT	ILOPERIDONE	TABLET;ORAL	6MG	Yes	No
005	FANAPT	ILOPERIDONE	TABLET;ORAL	8MG	Yes	No
006	FANAPT	ILOPERIDONE	TABLET;ORAL	10MG	Yes	No
007	FANAPT	ILOPERIDONE	TABLET;ORAL	12MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022192-001	FANAPT	ILOPERIDONE	1MG	TABLET / ORAL	RLD, RS	2009-05-06
N022192-002	FANAPT	ILOPERIDONE	2MG	TABLET / ORAL	RLD	2009-05-06
N022192-003	FANAPT	ILOPERIDONE	4MG	TABLET / ORAL	RLD	2009-05-06
N022192-004	FANAPT	ILOPERIDONE	6MG	TABLET / ORAL	RLD	2009-05-06
N022192-005	FANAPT	ILOPERIDONE	8MG	TABLET / ORAL	RLD	2009-05-06
N022192-006	FANAPT	ILOPERIDONE	10MG	TABLET / ORAL	RLD	2009-05-06
N022192-007	FANAPT	ILOPERIDONE	12MG	TABLET / ORAL	RLD	2009-05-06

Orange Book patents#

Current patent rows page 1 of 2 · 98 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022192-001	8586610	2027-11-02	U-1625	2015-01-08
N022192-001	10570453	2028-03-28	U-4562	2026-07-09
N022192-001	10570453	2028-03-28	U-4563	2026-07-09
N022192-001	9157121	2030-04-05	U-1674	2015-10-13
N022192-001	10563259	2030-07-24	U-4562	2026-07-09
N022192-001	10563259	2030-07-24	U-4563	2026-07-09
N022192-001	8652776	2030-08-31	U-1685	2015-04-30
N022192-001	12606869	2030-09-22	U-4504	2026-05-21
N022192-001	12606869	2030-09-22	U-4505	2026-05-21
N022192-001	8999638	2030-10-28	U-1674	2015-04-07
N022192-001	9074255	2030-12-17	U-1674	2015-07-28
N022192-001	9072742	2031-01-16	U-1674	2015-07-28
N022192-001	9074256	2031-02-10	U-1674	2015-07-28
N022192-001	9074254	2031-12-28	U-1674	2015-07-28
N022192-002	8586610	2027-11-02	U-1625	2015-01-08
N022192-002	10570453	2028-03-28	U-4562	2026-07-09
N022192-002	10570453	2028-03-28	U-4563	2026-07-09
N022192-002	9157121	2030-04-05	U-1674	2015-10-13
N022192-002	10563259	2030-07-24	U-4562	2026-07-09
N022192-002	10563259	2030-07-24	U-4563	2026-07-09
N022192-002	8652776	2030-08-31	U-1685	2015-04-30
N022192-002	12606869	2030-09-22	U-4504	2026-05-21
N022192-002	12606869	2030-09-22	U-4505	2026-05-21
N022192-002	8999638	2030-10-28	U-1674	2015-04-07
N022192-002	9074255	2030-12-17	U-1674	2015-07-28
N022192-002	9072742	2031-01-16	U-1674	2015-07-28
N022192-002	9074256	2031-02-10	U-1674	2015-07-28
N022192-002	9074254	2031-12-28	U-1674	2015-07-28
N022192-003	8586610	2027-11-02	U-1625	2015-01-08
N022192-003	10570453	2028-03-28	U-4562	2026-07-09
N022192-003	10570453	2028-03-28	U-4563	2026-07-09
N022192-003	9157121	2030-04-05	U-1674	2015-10-13
N022192-003	10563259	2030-07-24	U-4562	2026-07-09
N022192-003	10563259	2030-07-24	U-4563	2026-07-09
N022192-003	8652776	2030-08-31	U-1685	2015-04-30
N022192-003	12606869	2030-09-22	U-4504	2026-05-21
N022192-003	12606869	2030-09-22	U-4505	2026-05-21
N022192-003	8999638	2030-10-28	U-1674	2015-04-07
N022192-003	9074255	2030-12-17	U-1674	2015-07-28
N022192-003	9072742	2031-01-16	U-1674	2015-07-28
N022192-003	9074256	2031-02-10	U-1674	2015-07-28
N022192-003	9074254	2031-12-28	U-1674	2015-07-28
N022192-004	8586610	2027-11-02	U-1625	2015-01-08
N022192-004	10570453	2028-03-28	U-4562	2026-07-09
N022192-004	10570453	2028-03-28	U-4563	2026-07-09
N022192-004	9157121	2030-04-05	U-1674	2015-10-13
N022192-004	10563259	2030-07-24	U-4562	2026-07-09
N022192-004	10563259	2030-07-24	U-4563	2026-07-09
N022192-004	8652776	2030-08-31	U-1685	2015-04-30
N022192-004	12606869	2030-09-22	U-4504	2026-05-21
N022192-004	12606869	2030-09-22	U-4505	2026-05-21
N022192-004	8999638	2030-10-28	U-1674	2015-04-07
N022192-004	9074255	2030-12-17	U-1674	2015-07-28
N022192-004	9072742	2031-01-16	U-1674	2015-07-28
N022192-004	9074256	2031-02-10	U-1674	2015-07-28
N022192-004	9074254	2031-12-28	U-1674	2015-07-28
N022192-005	8586610	2027-11-02	U-1625	2015-01-08
N022192-005	10570453	2028-03-28	U-4562	2026-07-09
N022192-005	10570453	2028-03-28	U-4563	2026-07-09
N022192-005	9157121	2030-04-05	U-1674	2015-10-13
N022192-005	10563259	2030-07-24	U-4562	2026-07-09
N022192-005	10563259	2030-07-24	U-4563	2026-07-09
N022192-005	8652776	2030-08-31	U-1685	2015-04-30
N022192-005	12606869	2030-09-22	U-4504	2026-05-21
N022192-005	12606869	2030-09-22	U-4505	2026-05-21
N022192-005	8999638	2030-10-28	U-1674	2015-04-07
N022192-005	9074255	2030-12-17	U-1674	2015-07-28
N022192-005	9072742	2031-01-16	U-1674	2015-07-28
N022192-005	9074256	2031-02-10	U-1674	2015-07-28
N022192-005	9074254	2031-12-28	U-1674	2015-07-28
N022192-006	8586610	2027-11-02	U-1625	2015-01-08
N022192-006	10570453	2028-03-28	U-4562	2026-07-09
N022192-006	10570453	2028-03-28	U-4563	2026-07-09
N022192-006	9157121	2030-04-05	U-1674	2015-10-13
N022192-006	10563259	2030-07-24	U-4562	2026-07-09
N022192-006	10563259	2030-07-24	U-4563	2026-07-09
N022192-006	8652776	2030-08-31	U-1685	2015-04-30
N022192-006	12606869	2030-09-22	U-4504	2026-05-21
N022192-006	12606869	2030-09-22	U-4505	2026-05-21
N022192-006	8999638	2030-10-28	U-1674	2015-04-07

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 7 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022192-001	I-939	2027-04-02
N022192-002	I-939	2027-04-02
N022192-003	I-939	2027-04-02
N022192-004	I-939	2027-04-02
N022192-005	I-939	2027-04-02
N022192-006	I-939	2027-04-02
N022192-007	I-939	2027-04-02

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 8 · 287 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	N022192-001	FANAPT	1MG	TABLET / ORAL	RLD, RS	2009-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-002	FANAPT	2MG	TABLET / ORAL	RLD	2009-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-003	FANAPT	4MG	TABLET / ORAL	RLD	2009-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-004	FANAPT	6MG	TABLET / ORAL	RLD	2009-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-005	FANAPT	8MG	TABLET / ORAL	RLD	2009-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-006	FANAPT	10MG	TABLET / ORAL	RLD	2009-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-007	FANAPT	12MG	TABLET / ORAL	RLD	2009-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-001	FANAPT	1MG	TABLET / ORAL	RLD, RS	2009-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-002	FANAPT	2MG	TABLET / ORAL	RLD	2009-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-003	FANAPT	4MG	TABLET / ORAL	RLD	2009-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-004	FANAPT	6MG	TABLET / ORAL	RLD	2009-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-005	FANAPT	8MG	TABLET / ORAL	RLD	2009-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-006	FANAPT	10MG	TABLET / ORAL	RLD	2009-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-007	FANAPT	12MG	TABLET / ORAL	RLD	2009-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022192-001	FANAPT	1MG	TABLET / ORAL	RLD, RS	2009-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-002	FANAPT	2MG	TABLET / ORAL	RLD	2009-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-003	FANAPT	4MG	TABLET / ORAL	RLD	2009-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-004	FANAPT	6MG	TABLET / ORAL	RLD	2009-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-005	FANAPT	8MG	TABLET / ORAL	RLD	2009-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-006	FANAPT	10MG	TABLET / ORAL	RLD	2009-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-007	FANAPT	12MG	TABLET / ORAL	RLD	2009-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-001	FANAPT	1MG	TABLET / ORAL	RLD, RS	2009-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-002	FANAPT	2MG	TABLET / ORAL	RLD	2009-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-003	FANAPT	4MG	TABLET / ORAL	RLD	2009-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-004	FANAPT	6MG	TABLET / ORAL	RLD	2009-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-005	FANAPT	8MG	TABLET / ORAL	RLD	2009-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-006	FANAPT	10MG	TABLET / ORAL	RLD	2009-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-007	FANAPT	12MG	TABLET / ORAL	RLD	2009-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-001	FANAPT	1MG	TABLET / ORAL	RLD, RS	2009-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-002	FANAPT	2MG	TABLET / ORAL	RLD	2009-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-003	FANAPT	4MG	TABLET / ORAL	RLD	2009-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-004	FANAPT	6MG	TABLET / ORAL	RLD	2009-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-005	FANAPT	8MG	TABLET / ORAL	RLD	2009-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-006	FANAPT	10MG	TABLET / ORAL	RLD	2009-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-007	FANAPT	12MG	TABLET / ORAL	RLD	2009-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022192-001	FANAPT	1MG	TABLET / ORAL	RLD, RS	2009-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022192-002	FANAPT	2MG	TABLET / ORAL	RLD	2009-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022192-003	FANAPT	4MG	TABLET / ORAL	RLD	2009-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022192-004	FANAPT	6MG	TABLET / ORAL	RLD	2009-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022192-005	FANAPT	8MG	TABLET / ORAL	RLD	2009-05-06	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-006	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022192-007	AB	1	`5c6f7cd8ea54…`
2019-07-19 19:46 UTC	2019-07	N022192-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022192-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022192-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022192-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022192-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022192-006	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022192-007	AB	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-004	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-005	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-006	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022192-007	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 66 · 2,611 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022192-001	8586610	2027-11-02	U-1625	2015-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-001	9157121	2030-04-05	U-1674	2015-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-001	8652776	2030-08-31	U-1685	2015-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-001	8999638	2030-10-28	U-1674	2015-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-001	9074255	2030-12-17	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-001	9072742	2031-01-16	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-001	9074256	2031-02-10	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-001	9074254	2031-12-28	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-002	8586610	2027-11-02	U-1625	2015-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-002	9157121	2030-04-05	U-1674	2015-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-002	8652776	2030-08-31	U-1685	2015-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-002	8999638	2030-10-28	U-1674	2015-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-002	9074255	2030-12-17	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-002	9072742	2031-01-16	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-002	9074256	2031-02-10	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-002	9074254	2031-12-28	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-003	8586610	2027-11-02	U-1625	2015-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-003	9157121	2030-04-05	U-1674	2015-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-003	8652776	2030-08-31	U-1685	2015-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-003	8999638	2030-10-28	U-1674	2015-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-003	9074255	2030-12-17	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-003	9072742	2031-01-16	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-003	9074256	2031-02-10	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-003	9074254	2031-12-28	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-004	8586610	2027-11-02	U-1625	2015-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-004	9157121	2030-04-05	U-1674	2015-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-004	8652776	2030-08-31	U-1685	2015-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-004	8999638	2030-10-28	U-1674	2015-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-004	9074255	2030-12-17	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-004	9072742	2031-01-16	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-004	9074256	2031-02-10	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-004	9074254	2031-12-28	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-005	8586610	2027-11-02	U-1625	2015-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-005	9157121	2030-04-05	U-1674	2015-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-005	8652776	2030-08-31	U-1685	2015-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-005	8999638	2030-10-28	U-1674	2015-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-005	9074255	2030-12-17	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-005	9072742	2031-01-16	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-005	9074256	2031-02-10	U-1674	2015-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-005	9074254	2031-12-28	U-1674	2015-07-28	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 133 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022192-001	I-939	2027-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-002	I-939	2027-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-003	I-939	2027-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-004	I-939	2027-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-005	I-939	2027-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-006	I-939	2027-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022192-007	I-939	2027-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-001	I-939	2027-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-002	I-939	2027-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-003	I-939	2027-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-004	I-939	2027-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-005	I-939	2027-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-006	I-939	2027-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022192-007	I-939	2027-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022192-001	I-939	2027-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-002	I-939	2027-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-003	I-939	2027-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-004	I-939	2027-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-005	I-939	2027-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-006	I-939	2027-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022192-007	I-939	2027-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-001	I-939	2027-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-002	I-939	2027-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-003	I-939	2027-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-004	I-939	2027-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-005	I-939	2027-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-006	I-939	2027-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022192-007	I-939	2027-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-001	I-939	2027-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-002	I-939	2027-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-003	I-939	2027-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-004	I-939	2027-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-005	I-939	2027-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-006	I-939	2027-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022192-007	I-939	2027-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022192-001	I-939	2027-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022192-002	I-939	2027-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022192-003	I-939	2027-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022192-004	I-939	2027-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022192-005	I-939	2027-04-02	`03ed91905a0d…`

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
FANAPT	ILOPERIDONE	Vanda Pharmaceuticals Inc.	33f60b40-3fca-11de-8f56-0002a5d5c51b	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022192 application number: NDA022192 ndc (product): 43068-108 ndc (product): 43068-104 ndc (product): 43068-902 ndc (product): 43068-101 ndc (product): 43068-901 ndc (product): 43068-113 ndc (product): 43068-112 ndc (product): 43068-102 ndc (product): 43068-106 ndc (product): 43068-110 ndc (product): 43068-903

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43068-101	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-101	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-102	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-102	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-104	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-104	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-106	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-106	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-108	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-108	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-110	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-110	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-112	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-112	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-113	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-113	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-901	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-901	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-902	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-902	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-903	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-903	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
69189-0597	FANAPT	Iloperidone	Avera McKennan Hospital	NDA	Current
69189-0665	Fanapt	iloperidone	Avera McKennan Hospital	NDA	Current
70518-1867	Fanapt	iloperidone	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81116	SUPPL	2025-02-06
81002	SUPPL	2025-02-05
78110	SUPPL	2024-04-18
78050	SUPPL	2024-04-03
47403	SUPPL	2017-03-02
47402	SUPPL	2017-03-02
47311	SUPPL	2017-02-24
47310	SUPPL	2017-02-24
17063	SUPPL	2016-06-01
29384	SUPPL	2016-05-27
17064	SUPPL	2016-01-06
7022	SUPPL	2016-01-06
38364	SUPPL	2014-04-22
29383	SUPPL	2014-04-22
7020	SUPPL	2013-02-04
38362	SUPPL	2013-02-01
7021	SUPPL	2012-01-31
38363	SUPPL	2012-01-30
23701	ORIG	2011-12-22
38361	SUPPL	2011-09-12
17062	SUPPL	2011-09-12
7019	SUPPL	2011-09-12
7018	SUPPL	2011-09-12
17061	SUPPL	2011-03-28
7017	SUPPL	2011-03-24
29382	SUPPL	2010-12-06
38360	SUPPL	2010-12-04
38359	SUPPL	2010-08-27
29381	SUPPL	2010-08-26
24254	ORIG	2009-06-12
21955	ORIG	2009-06-12
17060	ORIG	2009-05-11
7016	ORIG	2009-05-11