GE HEALTHCARE FDA Approval NDA 017655

NDA 017655

GE HEALTHCARE

FDA Drug Application

Application #017655

Application Sponsors

NDA 017655GE HEALTHCARE

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION2mCi/ML0NEOSCANGALLIUM CITRATE GA-67

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1978-05-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1979-12-26STANDARD
EFFICACY; EfficacySUPPL4AP1985-07-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1990-08-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1986-05-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1990-12-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1995-03-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1995-03-06STANDARD

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL7Null0
SUPPL9Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17655
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOSCAN","activeIngredients":"GALLIUM CITRATE GA-67","strength":"2mCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEOSCAN","submission":"GALLIUM CITRATE GA-67","actionType":"2mCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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