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FDA NDA · NDA207356

ARIKAYCE

amikacin

Sponsor: INSMED INC

APPLICATION
NDA207356
TYPE
NDA
ORIGINAL APPROVAL
2018-09-28
LATEST ACTION
2026-06-25
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
SUSPENSION, LIPOSOMAL
MARKETING STATUS
Prescription

Products

ARIKAYCE KIT · ReferencePrescription
AMIKACIN SULFATE EQ 590MG BASE/8.4ML · SUSPENSION, LIPOSOMAL · INHALATION

Approval history

2026-06-25Labeling · Supplement 25 · standard — Letter ↗AP
2025-12-05Labeling · Supplement 19 · standard — Letter ↗AP
2023-06-01Labeling · Supplement 13 · standard — Letter ↗AP
2023-02-10Labeling · Supplement 12 · standard — Letter ↗AP
2020-10-19Efficacy · Supplement 3 · standard — Letter ↗AP
2020-03-13Labeling · Supplement 4 · standard — Label ↗AP
2018-09-28Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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