← FDA DRUG APPROVALS

FDA NDA · NDA209176

RADICAVA

Sponsor: SHIONOGI

APPLICATION
NDA209176
TYPE
NDA
ORIGINAL APPROVAL
2017-05-05
LATEST ACTION
2022-11-18
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

RADICAVA · ReferenceDiscontinued
EDARAVONE 60MG/100ML (0.6MG/ML) · SOLUTION · INTRAVENOUS
RADICAVA · ReferenceDiscontinued
EDARAVONE 30MG/100ML (0.3MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2022-11-18Labeling · Supplement 12 · standard — Label ↗AP
2021-03-15Labeling · Supplement 10 · standard — Label ↗AP
2019-11-01Labeling · Supplement 9 · standard — Label ↗AP
2018-11-15Manufacturing (CMC) · Supplement 7 — Label ↗AP
2018-08-17Manufacturing (CMC) · Supplement 5AP
2017-05-05Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →