GE HEALTHCARE FDA Approval NDA 019862

NDA 019862

GE HEALTHCARE

FDA Drug Application

Application #019862

Documents

Letter2004-03-16
Letter2004-03-16
Label2004-03-16
Label2004-03-16

Application Sponsors

NDA 019862GE HEALTHCARE

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION2mCi/0.2ML1INDICLORINDIUM IN-111 CHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1992-12-29STANDARD
EFFICACY; EfficacySUPPL3AP1996-10-28UNKNOWN
LABELING; LabelingSUPPL6AP2002-02-19STANDARD
LABELING; LabelingSUPPL12AP2003-04-24STANDARD
LABELING; LabelingSUPPL14AP2003-07-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2014-06-20STANDARD

Submissions Property Types

SUPPL21Null0

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19862
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"INDICLOR","activeIngredients":"INDIUM IN-111 CHLORIDE","strength":"2mCi\/0.2ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/24\/2003","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/in111med042403LB.pdf\"}]","notes":""},{"actionDate":"02\/19\/2002","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/in111med021902LB.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"INDICLOR","submission":"INDIUM IN-111 CHLORIDE","actionType":"2mCi\/0.2ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2003-04-24
        )

)

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