Is Aadi Bioscience, Inc. FDA approved?

Aadi Bioscience, Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Aadi Bioscience, Inc. make?

1 product is listed under Aadi Bioscience, Inc. in the openFDA NDC Directory, most often as injection, powder, lyophilized, for suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Aadi Bioscience, Inc.

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

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Registered sites: 0
Active NDC listings: 1
Live patents: 7
Exclusivities: 1
Countries: 0

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8911786	FYARROsirolimus	product	Feb 2029
10206887	FYARROsirolimus	product	Apr 2030
10705070	FYARROsirolimus	product	Mar 2036
12061183	FYARROsirolimus	product	Mar 2036
10973806	FYARROsirolimus	use	Jun 2036
12133844	FYARROsirolimus	use	Jun 2036
11497737	FYARROsirolimus	product	Oct 2040

Product	Exclusivity	Until
FYARROSIROLIMUS	ODE-386 Orphan drug	Nov 2028

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
FYARRO	Sirolimus	injection, powder, lyophilized, for suspension, intravenous	80803-153NDA

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Enquiry

Common questions

Is Aadi Bioscience, Inc. FDA approved?: Aadi Bioscience, Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Aadi Bioscience, Inc. make?: 1 product is listed under Aadi Bioscience, Inc. in the openFDA NDC Directory, most often as injection, powder, lyophilized, for suspension. 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.