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General MedicationsNASALStandard

NATESTO

TESTOSTERONE

Standard Dose
5.5MG/0.122GM ACTUATION
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription

Key Takeaways

  • Primary indication: Review priority: STANDARD Marketing status: Prescription
  • Approval overview NATESTO is listed in Drugs@FDA under application 205488 (NDA).
  • Review priority: STANDARD Marketing status: Prescription Active ingredient TESTOSTERONE Form and strength GEL, METERED;NASAL - 5.5MG/0.122GM ACTUATION Sponsor ACERUS Submission history Latest submission status date: 2025-07-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview NATESTO is listed in Drugs@FDA under application 205488 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TESTOSTERONE Form and strength GEL, METERED;NASAL - 5.5MG/0.122GM ACTUATION Sponsor ACERUS 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.