GE HEALTHCARE FDA Approval NDA 017784

NDA 017784

GE HEALTHCARE

FDA Drug Application

Application #017784

Application Sponsors

NDA 017784GE HEALTHCARE

Marketing Status

Discontinued001

Application Products

001SOLUTION;INJECTION, ORALN/A0TECHNETIUM TC 99M TSCTECHNETIUM TC-99M SULFUR COLLOID KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1976-11-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1977-08-09STANDARD
LABELING; LabelingSUPPL3AP1977-09-13STANDARD
LABELING; LabelingSUPPL4AP1977-09-12STANDARD
LABELING; LabelingSUPPL6AP1979-10-09STANDARD
LABELING; LabelingSUPPL7AP1978-08-28STANDARD
LABELING; LabelingSUPPL10AP1982-08-12STANDARD
LABELING; LabelingSUPPL11AP1981-04-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1982-12-07STANDARD
LABELING; LabelingSUPPL13AP1982-12-07STANDARD
LABELING; LabelingSUPPL14AP1985-04-19STANDARD
EFFICACY; EfficacySUPPL15AP1987-07-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1988-12-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1989-02-17STANDARD
LABELING; LabelingSUPPL19AP1988-12-15STANDARD

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL6Null0
SUPPL7Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL17Null0
SUPPL18Null0
SUPPL19Null0

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17784
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECHNETIUM TC 99M TSC","activeIngredients":"TECHNETIUM TC-99M SULFUR COLLOID KIT","strength":"N\/A","dosageForm":"SOLUTION;INJECTION, ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TECHNETIUM TC 99M TSC","submission":"TECHNETIUM TC-99M SULFUR COLLOID KIT","actionType":"N\/A","submissionClassification":"SOLUTION;INJECTION, ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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