NDA 018536

MALLINCKRODT

FDA Drug Application

Application #018536

Application Sponsors

NDA 018536

MALLINCKRODT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	GAS;INHALATION	5mCi/VIAL	0	XENON XE 127	XENON XE-127
002	GAS;INHALATION	10mCi/VIAL	0	XENON XE 127	XENON XE-127

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1982-10-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-06-21	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18536
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"XENON XE 127","activeIngredients":"XENON XE-127","strength":"5mCi\/VIAL","dosageForm":"GAS;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"XENON XE 127","activeIngredients":"XENON XE-127","strength":"10mCi\/VIAL","dosageForm":"GAS;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"XENON XE 127","submission":"XENON XE-127","actionType":"5mCi\/VIAL","submissionClassification":"GAS;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"XENON XE 127","submission":"XENON XE-127","actionType":"10mCi\/VIAL","submissionClassification":"GAS;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)