NDA 022290

GE HEALTHCARE

FDA Drug Application

Application #022290

Documents

• Letter: 2008-09-23
• Letter: 2013-03-22
• Review: 2008-10-23
• Summary Review: 2008-10-23
• Label: 2008-09-19
• Label: 2013-03-26
• Label: 2020-03-06
• Letter: 2020-03-09

Application Sponsors

NDA 022290

GE HEALTHCARE

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

10mCi/5ML (2mCi/ML)

1

ADREVIEW

IOBENGUANE SULFATE I-123

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2008-09-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2016-06-06	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2020-03-05	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	4	Null	14
SUPPL	5	Null	6

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22290
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADREVIEW","activeIngredients":"IOBENGUANE SULFATE I-123","strength":"10mCi\/5ML (2mCi\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/05\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022290s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2013","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022290s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/22290lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ADREVIEW","submission":"IOBENGUANE SULFATE I-123","actionType":"10mCi\/5ML (2mCi\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-03-05
        )

)