Application 216665

Type: NDA
Sponsor: SOLENO THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VYKAT XR	DIAZOXIDE CHOLINE	TABLET, EXTENDED RELEASE;ORAL	25MG	Yes	No
002	VYKAT XR	DIAZOXIDE CHOLINE	TABLET, EXTENDED RELEASE;ORAL	75MG	Yes	No
003	VYKAT XR	DIAZOXIDE CHOLINE	TABLET, EXTENDED RELEASE;ORAL	150MG	Yes	Yes

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

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	RLD / RS	Approval date
N216665-001	VYKAT XR	DIAZOXIDE CHOLINE	25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26
N216665-002	VYKAT XR	DIAZOXIDE CHOLINE	75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26
N216665-003	VYKAT XR	DIAZOXIDE CHOLINE	150MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2025-03-26

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216665-001	7572789	2026-12-20		Drug substance, Drug product	2025-04-23
N216665-001	7799777	2029-03-05		Drug substance	2025-04-23
N216665-001	12178823	2035-11-12	U-4167		2025-04-23
N216665-001	12343348	2035-11-12	U-4211		2025-07-03
N216665-001	12419895	2035-11-12	U-4275		2025-10-06
N216665-001	9757384	2035-11-12	U-4167		2025-04-23
N216665-002	7572789	2026-12-20		Drug substance, Drug product	2025-04-23
N216665-002	7799777	2029-03-05		Drug substance	2025-04-23
N216665-002	12178823	2035-11-12	U-4167		2025-04-23
N216665-002	12343348	2035-11-12	U-4211		2025-07-03
N216665-002	12419895	2035-11-12	U-4275		2025-10-06
N216665-002	9757384	2035-11-12	U-4167		2025-04-23
N216665-003	7572789	2026-12-20		Drug substance, Drug product	2025-04-23
N216665-003	7799777	2029-03-05		Drug substance	2025-04-23
N216665-003	12178823	2035-11-12	U-4167		2025-04-23
N216665-003	12343348	2035-11-12	U-4211		2025-07-03
N216665-003	12419895	2035-11-12	U-4275		2025-10-06
N216665-003	9757384	2035-11-12	U-4167		2025-04-23

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216665-001	NP	2028-03-26
N216665-001	ODE-532	2032-03-26
N216665-002	NP	2028-03-26
N216665-002	ODE-532	2032-03-26
N216665-003	NP	2028-03-26
N216665-003	ODE-532	2032-03-26

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	N216665-001	VYKAT XR	25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-002	VYKAT XR	75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-003	VYKAT XR	150MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2025-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216665-001	VYKAT XR	25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-002	VYKAT XR	75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-003	VYKAT XR	150MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2025-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216665-001	VYKAT XR	25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216665-002	VYKAT XR	75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216665-003	VYKAT XR	150MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2025-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216665-001	VYKAT XR	25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216665-002	VYKAT XR	75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216665-003	VYKAT XR	150MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2025-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216665-001	VYKAT XR	25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216665-002	VYKAT XR	75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216665-003	VYKAT XR	150MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2025-03-26	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216665-001	VYKAT XR	25MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216665-002	VYKAT XR	75MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2025-03-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216665-003	VYKAT XR	150MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2025-03-26	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N216665-001	7572789	2026-12-20		Drug substance, Drug product	2025-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-001	7799777	2029-03-05		Drug substance	2025-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-001	12178823	2035-11-12	U-4167		2025-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-001	12343348	2035-11-12	U-4211		2025-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-001	12419895	2035-11-12	U-4275		2025-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-001	9757384	2035-11-12	U-4167		2025-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-002	7572789	2026-12-20		Drug substance, Drug product	2025-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-002	7799777	2029-03-05		Drug substance	2025-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-002	12178823	2035-11-12	U-4167		2025-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-002	12343348	2035-11-12	U-4211		2025-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-002	12419895	2035-11-12	U-4275		2025-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-002	9757384	2035-11-12	U-4167		2025-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-003	7572789	2026-12-20		Drug substance, Drug product	2025-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-003	7799777	2029-03-05		Drug substance	2025-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-003	12178823	2035-11-12	U-4167		2025-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-003	12343348	2035-11-12	U-4211		2025-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-003	12419895	2035-11-12	U-4275		2025-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-003	9757384	2035-11-12	U-4167		2025-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216665-001	7572789	2026-12-20		Drug substance, Drug product	2025-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-001	7799777	2029-03-05		Drug substance	2025-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-001	12178823	2035-11-12	U-4167		2025-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-001	12343348	2035-11-12	U-4211		2025-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-001	12419895	2035-11-12	U-4275		2025-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-001	9757384	2035-11-12	U-4167		2025-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-002	7572789	2026-12-20		Drug substance, Drug product	2025-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-002	7799777	2029-03-05		Drug substance	2025-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-002	12178823	2035-11-12	U-4167		2025-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-002	12343348	2035-11-12	U-4211		2025-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-002	12419895	2035-11-12	U-4275		2025-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-002	9757384	2035-11-12	U-4167		2025-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-003	7572789	2026-12-20		Drug substance, Drug product	2025-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-003	7799777	2029-03-05		Drug substance	2025-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-003	12178823	2035-11-12	U-4167		2025-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-003	12343348	2035-11-12	U-4211		2025-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-003	12419895	2035-11-12	U-4275		2025-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-003	9757384	2035-11-12	U-4167		2025-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216665-001	7572789	2026-12-20		Drug substance, Drug product	2025-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216665-001	7799777	2029-03-05		Drug substance	2025-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216665-001	12178823	2035-11-12	U-4167		2025-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216665-001	12343348	2035-11-12	U-4211		2025-07-03	`011fe1cb6892…`

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	N216665-001	NP	2028-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-001	ODE-532	2032-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-002	NP	2028-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-002	ODE-532	2032-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-003	NP	2028-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216665-003	ODE-532	2032-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216665-001	NP	2028-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-001	ODE-532	2032-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-002	NP	2028-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-002	ODE-532	2032-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-003	NP	2028-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216665-003	ODE-532	2032-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216665-001	NP	2028-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216665-002	NP	2028-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216665-003	NP	2028-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216665-001	NP	2028-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216665-002	NP	2028-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216665-003	NP	2028-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216665-001	NP	2028-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216665-002	NP	2028-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216665-003	NP	2028-03-26	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216665-001	NP	2028-03-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216665-001	ODE-532	2032-03-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216665-002	NP	2028-03-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216665-002	ODE-532	2032-03-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216665-003	NP	2028-03-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216665-003	ODE-532	2032-03-26	`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
VYKAT XR	DIAZOXIDE CHOLINE	Soleno Therapeutics, Inc.	0e745e85-9512-e360-e063-6394a90aebf1	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216665 application number: NDA216665

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
85734	ORIG	2026-04-27
81766	ORIG	2025-03-28
81760	ORIG	2025-03-27
81747	ORIG	2025-03-27