NDA 017687

GE HEALTHCARE

FDA Drug Application

Application #017687

Application Sponsors

NDA 017687

GE HEALTHCARE

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	GAS;INHALATION	10mCi/VIAL	0	XENON XE 133-V.S.S.	XENON XE-133
002	GAS;INHALATION	10mCi/VIAL	0	XENON XE 133	XENON XE-133
003	GAS;INHALATION	20mCi/VIAL	0	XENON XE 133	XENON XE-133

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1976-11-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1981-02-27	STANDARD
LABELING; Labeling	SUPPL	4	AP	1986-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-05-22	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17687
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"XENON XE 133","activeIngredients":"XENON XE-133","strength":"10mCi\/VIAL","dosageForm":"GAS;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"XENON XE 133","activeIngredients":"XENON XE-133","strength":"20mCi\/VIAL","dosageForm":"GAS;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"XENON XE 133-V.S.S.","activeIngredients":"XENON XE-133","strength":"10mCi\/VIAL","dosageForm":"GAS;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"XENON XE 133","submission":"XENON XE-133","actionType":"10mCi\/VIAL","submissionClassification":"GAS;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"XENON XE 133","submission":"XENON XE-133","actionType":"20mCi\/VIAL","submissionClassification":"GAS;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"XENON XE 133-V.S.S.","submission":"XENON XE-133","actionType":"10mCi\/VIAL","submissionClassification":"GAS;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)