Is Marius Pharmaceuticals FDA approved?

Marius Pharmaceuticals 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 Marius Pharmaceuticals make?

3 products are listed under Marius Pharmaceuticals in the openFDA NDC Directory, most often as capsule, liquid filled. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Marius Pharmaceuticals

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
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
capsule, liquid filled	3

Route	NDCs
oral	3

Labeller name on the listing	NDCs
marius pharmaceuticals	3

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10576089	KYZATREXtestosterone undecanoate	product	Dec 2030
10576090	KYZATREXtestosterone undecanoate	product	Dec 2030
11590146	KYZATREXtestosterone undecanoate	product	Dec 2030
11617758	KYZATREXtestosterone undecanoate	product	Mar 2033
12357643	KYZATREXtestosterone undecanoate	product	Mar 2033
12403146	KYZATREXtestosterone undecanoate	product	Mar 2041

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Kyzatrex	TESTOSTERONE UNDECANOATE	capsule, liquid filled, oral	80603-103NDA
Kyzatrex	TESTOSTERONE UNDECANOATE	capsule, liquid filled, oral	80603-105NDA
Kyzatrex	TESTOSTERONE UNDECANOATE	capsule, liquid filled, oral	80603-107NDA

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LETCO MEDICAL, LLC1 site · 224 NDC

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Common questions

Is Marius Pharmaceuticals FDA approved?: Marius Pharmaceuticals 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 Marius Pharmaceuticals make?: 3 products are listed under Marius Pharmaceuticals in the openFDA NDC Directory, most often as capsule, liquid filled. 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.