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General MedicationsORALStandard

JATENZO

TESTOSTERONE UNDECANOATE

Standard Dose
198MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview JATENZO is listed in Drugs@FDA under application 206089 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient TESTOSTERONE UNDECANOATE Form and strength CAPSULE;ORAL - 198MG Sponsor TOLMAR Submission history Latest submission status date: 2025-09-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview JATENZO is listed in Drugs@FDA under application 206089 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TESTOSTERONE UNDECANOATE Form and strength CAPSULE;ORAL - 198MG Sponsor TOLMAR Submission history Latest submission status date: 2025-09-12 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.