Is Nuvation Bio Inc. FDA approved?

Nuvation Bio 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 Nuvation Bio Inc. make?

1 product is listed under Nuvation Bio Inc. in the openFDA NDC Directory, most often as capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Nuvation Bio 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: 2
Exclusivities: 1
Countries: 0

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
9187489	IBTROZItaletrectinib adipate	substance, product	Jun 2033
9751887	IBTROZItaletrectinib adipate	substance, product	Jun 2033

Product	Exclusivity	Until
IBTROZITALETRECTINIB ADIPATE	ODE-544 Orphan drug	Jun 2032

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
IBTROZI	taletrectinib	capsule, oral	84651-200NDA

Enquiry

Common questions

Is Nuvation Bio Inc. FDA approved?: Nuvation Bio 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 Nuvation Bio Inc. make?: 1 product is listed under Nuvation Bio Inc. in the openFDA NDC Directory, most often as capsule. 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.