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General MedicationsSUBCUTANEOUSStandard

XYOSTED (AUTOINJECTOR)

TESTOSTERONE ENANTHATE

Standard Dose
50MG/0.5ML (50MG/0.5ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview XYOSTED (AUTOINJECTOR) is listed in Drugs@FDA under application 209863 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient TESTOSTERONE ENANTHATE Form and strength SOLUTION;SUBCUTANEOUS - 50MG/0.5ML (50MG/0.5ML) Sponsor ANTARES PHARMA INC Submission history Latest submission status date: 2025-07-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview XYOSTED (AUTOINJECTOR) is listed in Drugs@FDA under application 209863 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TESTOSTERONE ENANTHATE Form and strength SOLUTION;SUBCUTANEOUS - 50MG/0.5ML (50MG/0.5ML) Sponsor ANTARES PHARMA INC 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.