KYZATREX (TESTOSTERONE UNDECANOATE)
Summary
FDA approved KYZATREX (TESTOSTERONE UNDECANOATE) by MARIUS. NDA (New Drug) approval (Labeling) on 2025-07-11. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
NDA213953-5
Action Date
2025-07-11
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
KYZATREX (generic: TESTOSTERONE UNDECANOATE), CAPSULE, ORAL. Application: NDA213953
Company
Context & Analysis
Frequently Asked Questions
How often does MARIUS have FDA actions?
This is the only FDA action we have on record for MARIUS in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA213953-5" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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