GE HEALTHCARE FDA Approval NDA 017700

NDA 017700

GE HEALTHCARE

FDA Drug Application

Application #017700

Application Sponsors

NDA 017700GE HEALTHCARE

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION1mCi/ML0GALLIUM CITRATE GA 67GALLIUM CITRATE GA-67

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1977-12-16STANDARD
LABELING; LabelingSUPPL2AP1979-08-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1978-08-23STANDARD

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17700
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"GALLIUM CITRATE GA 67","activeIngredients":"GALLIUM CITRATE GA-67","strength":"1mCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GALLIUM CITRATE GA 67","submission":"GALLIUM CITRATE GA-67","actionType":"1mCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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