NDA 018327

CURIUM

FDA Drug Application

Application #018327

Documents

• Label: 2016-03-14

Application Sponsors

NDA 018327

CURIUM

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	GAS;INHALATION	10mCi/VIAL	0	XENON XE 133	XENON XE-133
002	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	1982-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-09-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2016-03-09	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0

CDER Filings

CURIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18327
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"XENON XE 133","activeIngredients":"XENON XE-133","strength":"10mCi\/VIAL","dosageForm":"GAS;INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"XENON XE 133","activeIngredients":"XENON XE-133","strength":"20mCi\/VIAL","dosageForm":"GAS;INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/09\/2016","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018327s005lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"XENON XE 133","submission":"XENON XE-133","actionType":"10mCi\/VIAL","submissionClassification":"GAS;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"XENON XE 133","submission":"XENON XE-133","actionType":"20mCi\/VIAL","submissionClassification":"GAS;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2016-03-09
        )

)