APPLICATION
NDA017550
TYPE
NDA
ORIGINAL APPROVAL
1976-03-24
LATEST ACTION
1986-07-31
ROUTE
INHALATION
DOSAGE FORM
GAS
MARKETING STATUS
Discontinued
Products
XENON XE 133Discontinued
XENON XE-133 0.25-5 CI/AMP · GAS · INHALATION
XENON XE 133Discontinued
XENON XE-133 5-100 CI/CYLINDER · GAS · INHALATION
Approval history
1986-07-31Labeling · Supplement 6AP
1986-05-30Labeling · Supplement 5AP
1979-12-12Manufacturing (CMC) · Supplement 3 · standardAP
1976-03-24Type 5 - New Formulation or New Manufacturer · Original · standardAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.