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General MedicationsSUBCUTANEOUSStandard

WAINUA (AUTOINJECTOR)

EPLONTERSEN SODIUM

Standard Dose
EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview WAINUA (AUTOINJECTOR) is listed in Drugs@FDA under application 217388 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient EPLONTERSEN SODIUM Form and strength SOLUTION;SUBCUTANEOUS - EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2025-12-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview WAINUA (AUTOINJECTOR) is listed in Drugs@FDA under application 217388 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient EPLONTERSEN SODIUM Form and strength SOLUTION;SUBCUTANEOUS - EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2025-12-17 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.