← FDA DRUG APPROVALS

FDA NDA · NDA018536

XENON XE 127

Sponsor: MALLINCKRODT

APPLICATION
NDA018536
TYPE
NDA
ORIGINAL APPROVAL
1982-10-01
LATEST ACTION
1983-11-18
ROUTE
INHALATION
DOSAGE FORM
GAS
MARKETING STATUS
Discontinued

Products

XENON XE 127Discontinued
XENON XE-127 5mCi/VIAL · GAS · INHALATION
XENON XE 127Discontinued
XENON XE-127 10mCi/VIAL · GAS · INHALATION

Approval history

1983-11-18Manufacturing (CMC) · Supplement 1 · standardAP
1983-06-21Manufacturing (CMC) · Supplement 2 · standardAP
1982-10-01Type 1 - New Molecular Entity · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →