NDA 017042

GE HEALTHCARE

FDA Drug Application

Application #017042

Application Sponsors

NDA 017042

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INTRAVENOUS

2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

FLUORINE F-18

SODIUM FLUORIDE F-18

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

1972-02-24

PRIORITY

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17042
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUORINE F-18","activeIngredients":"SODIUM FLUORIDE F-18","strength":"2mCi\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUORINE F-18","submission":"SODIUM FLUORIDE F-18","actionType":"2mCi\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)