Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsINHALATIONStandard

ARIKAYCE KIT

AMIKACIN SULFATE

Standard Dose
EQ 590MG BASE/8.4ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ARIKAYCE KIT is listed in Drugs@FDA under application 207356 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMIKACIN SULFATE Form and strength SUSPENSION, LIPOSOMAL;INHALATION - EQ 590MG BASE/8.4ML Sponsor INSMED INC Submission history Latest submission status date: 2025-12-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview ARIKAYCE KIT is listed in Drugs@FDA under application 207356 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMIKACIN SULFATE Form and strength SUSPENSION, LIPOSOMAL;INHALATION - EQ 590MG BASE/8.4ML Sponsor INSMED INC Submission history Latest submission status date: 2025-12-05 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
ARIKAYCE KIT (AMIKACIN SULFATE) | Drug Monograph | MedicHelpline