Is Soleno Therapeutics, Inc. FDA approved?

Soleno Therapeutics, Inc. holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Soleno Therapeutics, Inc. make?

3 products are listed under Soleno Therapeutics, Inc. in the openFDA NDC Directory, most often as tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Soleno Therapeutics, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 3
Live patents: 18
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human prescription drug. By marketing category: NDA 3.

Dosage form	NDCs
tablet, film coated	3

Route	NDCs
oral	3

Labeller name on the listing	NDCs
soleno therapeutics, inc.	3

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
7572789	VYKAT XRdiazoxide choline	substance, product	Dec 2026
7799777	VYKAT XRdiazoxide choline	substance	Mar 2029
12178823	VYKAT XRdiazoxide choline	use	Nov 2035
12343348	VYKAT XRdiazoxide choline	use	Nov 2035
12419895	VYKAT XRdiazoxide choline	use	Nov 2035
9757384	VYKAT XRdiazoxide choline	use	Nov 2035

Product	Exclusivity	Until
VYKAT XRDIAZOXIDE CHOLINE	ODE-532 Orphan drug	Mar 2032

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
VYKAT XR	diazoxide choline	tablet, film coated, oral	83860-025NDA
VYKAT XR	diazoxide choline	tablet, film coated, oral	83860-075NDA
VYKAT XR	diazoxide choline	tablet, film coated, oral	83860-150NDA

Enquiry

Common questions

Is Soleno Therapeutics, Inc. FDA approved?: Soleno Therapeutics, Inc. holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Soleno Therapeutics, Inc. make?: 3 products are listed under Soleno Therapeutics, Inc. in the openFDA NDC Directory, most often as tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.