Application 220358

Type: NDA
Sponsor: VANDA PHARMS INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N220358-001	BYSANTI	MILSAPERIDONE	1MG	TABLET / ORAL	RLD, RS	2026-02-20
N220358-002	BYSANTI	MILSAPERIDONE	2MG	TABLET / ORAL	RLD	2026-02-20
N220358-003	BYSANTI	MILSAPERIDONE	4MG	TABLET / ORAL	RLD	2026-02-20
N220358-004	BYSANTI	MILSAPERIDONE	6MG	TABLET / ORAL	RLD	2026-02-20
N220358-005	BYSANTI	MILSAPERIDONE	8MG	TABLET / ORAL	RLD	2026-02-20
N220358-006	BYSANTI	MILSAPERIDONE	10MG	TABLET / ORAL	RLD	2026-02-20
N220358-007	BYSANTI	MILSAPERIDONE	12MG	TABLET / ORAL	RLD	2026-02-20

Orange Book patents#

Current patent rows page 1 of 2 · 140 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N220358-001	10570453	2028-03-28	U-4436	2026-03-23
N220358-001	10570453	2028-03-28	U-4437	2026-03-23
N220358-001	9157121	2030-04-05	U-4436	2026-03-23
N220358-001	9157121	2030-04-05	U-4437	2026-03-23
N220358-001	10563259	2030-07-24	U-4436	2026-03-23
N220358-001	10563259	2030-07-24	U-4437	2026-03-23
N220358-001	12606869	2030-09-22	U-4506	2026-05-21
N220358-001	12606869	2030-09-22	U-4507	2026-05-21
N220358-001	8999638	2030-10-28	U-4436	2026-03-23
N220358-001	8999638	2030-10-28	U-4437	2026-03-23
N220358-001	9074255	2030-12-17	U-4436	2026-03-23
N220358-001	9074255	2030-12-17	U-4437	2026-03-23
N220358-001	9072742	2031-01-16	U-4436	2026-03-23
N220358-001	9072742	2031-01-16	U-4437	2026-03-23
N220358-001	9074256	2031-02-10	U-4436	2026-03-23
N220358-001	9074256	2031-02-10	U-4437	2026-03-23
N220358-001	9074254	2031-12-28	U-4436	2026-03-23
N220358-001	9074254	2031-12-28	U-4437	2026-03-23
N220358-001	12478619	2044-05-31	U-4434	2026-03-23
N220358-001	12478619	2044-05-31	U-4435	2026-03-23
N220358-002	10570453	2028-03-28	U-4436	2026-03-23
N220358-002	10570453	2028-03-28	U-4437	2026-03-23
N220358-002	9157121	2030-04-05	U-4436	2026-03-23
N220358-002	9157121	2030-04-05	U-4437	2026-03-23
N220358-002	10563259	2030-07-24	U-4436	2026-03-23
N220358-002	10563259	2030-07-24	U-4437	2026-03-23
N220358-002	12606869	2030-09-22	U-4506	2026-05-21
N220358-002	12606869	2030-09-22	U-4507	2026-05-21
N220358-002	8999638	2030-10-28	U-4436	2026-03-23
N220358-002	8999638	2030-10-28	U-4437	2026-03-23
N220358-002	9074255	2030-12-17	U-4436	2026-03-23
N220358-002	9074255	2030-12-17	U-4437	2026-03-23
N220358-002	9072742	2031-01-16	U-4436	2026-03-23
N220358-002	9072742	2031-01-16	U-4437	2026-03-23
N220358-002	9074256	2031-02-10	U-4436	2026-03-23
N220358-002	9074256	2031-02-10	U-4437	2026-03-23
N220358-002	9074254	2031-12-28	U-4436	2026-03-23
N220358-002	9074254	2031-12-28	U-4437	2026-03-23
N220358-002	12478619	2044-05-31	U-4434	2026-03-23
N220358-002	12478619	2044-05-31	U-4435	2026-03-23
N220358-003	10570453	2028-03-28	U-4436	2026-03-23
N220358-003	10570453	2028-03-28	U-4437	2026-03-23
N220358-003	9157121	2030-04-05	U-4436	2026-03-23
N220358-003	9157121	2030-04-05	U-4437	2026-03-23
N220358-003	10563259	2030-07-24	U-4436	2026-03-23
N220358-003	10563259	2030-07-24	U-4437	2026-03-23
N220358-003	12606869	2030-09-22	U-4506	2026-05-21
N220358-003	12606869	2030-09-22	U-4507	2026-05-21
N220358-003	8999638	2030-10-28	U-4436	2026-03-23
N220358-003	8999638	2030-10-28	U-4437	2026-03-23
N220358-003	9074255	2030-12-17	U-4436	2026-03-23
N220358-003	9074255	2030-12-17	U-4437	2026-03-23
N220358-003	9072742	2031-01-16	U-4436	2026-03-23
N220358-003	9072742	2031-01-16	U-4437	2026-03-23
N220358-003	9074256	2031-02-10	U-4436	2026-03-23
N220358-003	9074256	2031-02-10	U-4437	2026-03-23
N220358-003	9074254	2031-12-28	U-4436	2026-03-23
N220358-003	9074254	2031-12-28	U-4437	2026-03-23
N220358-003	12478619	2044-05-31	U-4434	2026-03-23
N220358-003	12478619	2044-05-31	U-4435	2026-03-23
N220358-004	10570453	2028-03-28	U-4436	2026-03-23
N220358-004	10570453	2028-03-28	U-4437	2026-03-23
N220358-004	9157121	2030-04-05	U-4436	2026-03-23
N220358-004	9157121	2030-04-05	U-4437	2026-03-23
N220358-004	10563259	2030-07-24	U-4436	2026-03-23
N220358-004	10563259	2030-07-24	U-4437	2026-03-23
N220358-004	12606869	2030-09-22	U-4506	2026-05-21
N220358-004	12606869	2030-09-22	U-4507	2026-05-21
N220358-004	8999638	2030-10-28	U-4436	2026-03-23
N220358-004	8999638	2030-10-28	U-4437	2026-03-23
N220358-004	9074255	2030-12-17	U-4436	2026-03-23
N220358-004	9074255	2030-12-17	U-4437	2026-03-23
N220358-004	9072742	2031-01-16	U-4436	2026-03-23
N220358-004	9072742	2031-01-16	U-4437	2026-03-23
N220358-004	9074256	2031-02-10	U-4436	2026-03-23
N220358-004	9074256	2031-02-10	U-4437	2026-03-23
N220358-004	9074254	2031-12-28	U-4436	2026-03-23
N220358-004	9074254	2031-12-28	U-4437	2026-03-23
N220358-004	12478619	2044-05-31	U-4434	2026-03-23
N220358-004	12478619	2044-05-31	U-4435	2026-03-23

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N220358-001	NCE	2031-02-20
N220358-002	NCE	2031-02-20
N220358-003	NCE	2031-02-20
N220358-004	NCE	2031-02-20
N220358-005	NCE	2031-02-20
N220358-006	NCE	2031-02-20
N220358-007	NCE	2031-02-20

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N220358-001	BYSANTI	1MG	TABLET / ORAL	RLD, RS	2026-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	BYSANTI	2MG	TABLET / ORAL	RLD	2026-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-003	BYSANTI	4MG	TABLET / ORAL	RLD	2026-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-004	BYSANTI	6MG	TABLET / ORAL	RLD	2026-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-005	BYSANTI	8MG	TABLET / ORAL	RLD	2026-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-006	BYSANTI	10MG	TABLET / ORAL	RLD	2026-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-007	BYSANTI	12MG	TABLET / ORAL	RLD	2026-02-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220358-001	BYSANTI	1MG	TABLET / ORAL	RLD, RS	2026-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220358-002	BYSANTI	2MG	TABLET / ORAL	RLD	2026-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220358-003	BYSANTI	4MG	TABLET / ORAL	RLD	2026-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220358-004	BYSANTI	6MG	TABLET / ORAL	RLD	2026-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220358-005	BYSANTI	8MG	TABLET / ORAL	RLD	2026-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220358-006	BYSANTI	10MG	TABLET / ORAL	RLD	2026-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220358-007	BYSANTI	12MG	TABLET / ORAL	RLD	2026-02-20	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-001	BYSANTI	1MG	TABLET / ORAL	RLD, RS	2026-02-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-002	BYSANTI	2MG	TABLET / ORAL	RLD	2026-02-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-003	BYSANTI	4MG	TABLET / ORAL	RLD	2026-02-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-004	BYSANTI	6MG	TABLET / ORAL	RLD	2026-02-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-005	BYSANTI	8MG	TABLET / ORAL	RLD	2026-02-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-006	BYSANTI	10MG	TABLET / ORAL	RLD	2026-02-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-007	BYSANTI	12MG	TABLET / ORAL	RLD	2026-02-20	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 420 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N220358-001	10570453	2028-03-28	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	10570453	2028-03-28	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	9157121	2030-04-05	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	9157121	2030-04-05	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	10563259	2030-07-24	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	10563259	2030-07-24	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	12606869	2030-09-22	U-4506	2026-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	12606869	2030-09-22	U-4507	2026-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	8999638	2030-10-28	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	8999638	2030-10-28	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	9074255	2030-12-17	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	9074255	2030-12-17	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	9072742	2031-01-16	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	9072742	2031-01-16	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	9074256	2031-02-10	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	9074256	2031-02-10	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	9074254	2031-12-28	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	9074254	2031-12-28	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	12478619	2044-05-31	U-4434	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-001	12478619	2044-05-31	U-4435	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	10570453	2028-03-28	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	10570453	2028-03-28	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	9157121	2030-04-05	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	9157121	2030-04-05	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	10563259	2030-07-24	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	10563259	2030-07-24	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	12606869	2030-09-22	U-4506	2026-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	12606869	2030-09-22	U-4507	2026-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	8999638	2030-10-28	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	8999638	2030-10-28	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	9074255	2030-12-17	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	9074255	2030-12-17	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	9072742	2031-01-16	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	9072742	2031-01-16	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	9074256	2031-02-10	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	9074256	2031-02-10	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	9074254	2031-12-28	U-4437	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	9074254	2031-12-28	U-4436	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	12478619	2044-05-31	U-4435	2026-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	12478619	2044-05-31	U-4434	2026-03-23	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N220358-001	NCE	2031-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-002	NCE	2031-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-003	NCE	2031-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-004	NCE	2031-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-005	NCE	2031-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-006	NCE	2031-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220358-007	NCE	2031-02-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220358-001	NCE	2031-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220358-002	NCE	2031-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220358-003	NCE	2031-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220358-004	NCE	2031-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220358-005	NCE	2031-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220358-006	NCE	2031-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220358-007	NCE	2031-02-20	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-001	NCE	2031-02-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-002	NCE	2031-02-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-003	NCE	2031-02-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-004	NCE	2031-02-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-005	NCE	2031-02-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-006	NCE	2031-02-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220358-007	NCE	2031-02-20	`a50c72e98297…`

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
BYSANTI	MILSAPERIDONE	Vanda Pharmaceuticals Inc.	254a1c01-4a4c-4bdd-85d6-1f23f2e4e6f8	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 220358 application number: NDA220358

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85314	ORIG	2026-03-10
85313	ORIG	2026-03-10
85157	ORIG	2026-02-25
85114	ORIG	2026-02-24