Is Xcovery Holdings, Inc. FDA approved?

Xcovery Holdings, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Xcovery Holdings, Inc. make?

2 products are listed under Xcovery Holdings, 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.

Xcovery Holdings, Inc.

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

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Registered sites: 0
Active NDC listings: 2
Live patents: 8
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
capsule	2

Route	NDCs
oral	2

Labeller name on the listing	NDCs
xcovery holdings, inc.	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8551995	ENSACOVEensartinib hydrochloride	substance	Feb 2029
9296724	ENSACOVEensartinib hydrochloride	substance	Jun 2029
9126947	ENSACOVEensartinib hydrochloride	substance	Nov 2031
10899744	ENSACOVEensartinib hydrochloride	substance	Jun 2037

Product	Exclusivity	Until
ENSACOVEENSARTINIB HYDROCHLORIDE	NCE New chemical entity	Dec 2029

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ENSACOVE	ensartinib	capsule, oral	83076-1025NDA
ENSACOVE	ensartinib	capsule, oral	83076-1100NDA

Enquiry

Common questions

Is Xcovery Holdings, Inc. FDA approved?: Xcovery Holdings, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Xcovery Holdings, Inc. make?: 2 products are listed under Xcovery Holdings, 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.