NDA 017256

GE HEALTHCARE

FDA Drug Application

Application #017256

Application Sponsors

NDA 017256

GE HEALTHCARE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	1.3-1.7 CI/AMP	0	XENON XE 133	XENON XE-133
002	GAS;INHALATION	1 CI/AMP	0	XENON XE 133	XENON XE-133

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1976-11-09	STANDARD
LABELING; Labeling	SUPPL	6	AP	1979-05-01
LABELING; Labeling	SUPPL	7	AP	1980-02-29
LABELING; Labeling	SUPPL	12	AP	2001-09-17
LABELING; Labeling	SUPPL	13	AP	2001-09-17

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17256
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"XENON XE 133","activeIngredients":"XENON XE-133","strength":"1.3-1.7 CI\/AMP","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"XENON XE 133","activeIngredients":"XENON XE-133","strength":"1 CI\/AMP","dosageForm":"GAS;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"XENON XE 133","submission":"XENON XE-133","actionType":"1.3-1.7 CI\/AMP","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"XENON XE 133","submission":"XENON XE-133","actionType":"1 CI\/AMP","submissionClassification":"GAS;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)