General MedicationsORALStandard
KYZATREX
TESTOSTERONE UNDECANOATE
Standard Dose
200MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview KYZATREX is listed in Drugs@FDA under application 213953 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TESTOSTERONE UNDECANOATE Form and strength CAPSULE;ORAL - 200MG Sponsor MARIUS Submission history Latest submission status date: 2025-07-11 00:00:00.
Structured Monograph
Clinical summary
Approval overview KYZATREX is listed in Drugs@FDA under application 213953 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TESTOSTERONE UNDECANOATE Form and strength CAPSULE;ORAL - 200MG Sponsor MARIUS Submission history Latest submission status date: 2025-07-11 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.