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General MedicationsSUBCUTANEOUSStandard

TYMLOS

ABALOPARATIDE

Standard Dose
3.12MG/1.56ML (2MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview TYMLOS is listed in Drugs@FDA under application 208743 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ABALOPARATIDE Form and strength SOLUTION;SUBCUTANEOUS - 3.12MG/1.56ML (2MG/ML) Sponsor RADIUS Submission history Latest submission status date: 2025-03-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview TYMLOS is listed in Drugs@FDA under application 208743 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ABALOPARATIDE Form and strength SOLUTION;SUBCUTANEOUS - 3.12MG/1.56ML (2MG/ML) Sponsor RADIUS Submission history Latest submission status date: 2025-03-28 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.