GE HEALTHCARE FDA Approval NDA 008032

NDA 008032

GE HEALTHCARE

FDA Drug Application

Application #008032

Application Sponsors

NDA 008032GE HEALTHCARE

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL500MG0TELEPAQUEIOPANOIC ACID

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1951-07-16PRIORITY
LABELING; LabelingSUPPL9AP1976-10-18PRIORITY
LABELING; LabelingSUPPL10AP1976-10-15PRIORITY
LABELING; LabelingSUPPL11AP1976-10-15PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1976-10-15PRIORITY
LABELING; LabelingSUPPL13AP1978-10-12PRIORITY
LABELING; LabelingSUPPL15AP1979-11-27PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1983-09-30PRIORITY
LABELING; LabelingSUPPL18AP1984-03-14PRIORITY
LABELING; LabelingSUPPL19AP1985-04-19PRIORITY
LABELING; LabelingSUPPL20AP1985-11-23PRIORITY
LABELING; LabelingSUPPL21AP1986-07-01PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1987-05-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL23AP1990-05-02PRIORITY

Submissions Property Types

ORIG1Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL15Null0
SUPPL17Null0
SUPPL18Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0
SUPPL23Null0

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 8032
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TELEPAQUE","activeIngredients":"IOPANOIC ACID","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TELEPAQUE","submission":"IOPANOIC ACID","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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