← FDA DRUG APPROVALS

FDA NDA · NDA018327

XENON, XE-133

xenon

Sponsor: CURIUM

APPLICATION
NDA018327
TYPE
NDA
ORIGINAL APPROVAL
1982-03-09
LATEST ACTION
2016-03-09
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
GAS
MARKETING STATUS
Prescription

Products

XENON XE 133Prescription
XENON XE-133 10mCi/VIAL · GAS · INHALATION
XENON XE 133Prescription
XENON XE-133 20mCi/VIAL · GAS · INHALATION

Approval history

2016-03-09Manufacturing (CMC) · Supplement 5 · standard — Label ↗AP
1997-09-19Manufacturing (CMC) · Supplement 3 · standardAP
1988-05-26Manufacturing (CMC) · Supplement 1 · standardAP
1982-03-09Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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