GE HEALTHCARE FDA Approval NDA 011386

NDA 011386

GE HEALTHCARE

FDA Drug Application

Application #011386

Application Sponsors

NDA 011386GE HEALTHCARE

Marketing Status

Discontinued001
Discontinued003

Application Products

001FOR SOLUTION;ORAL, RECTAL100%0HYPAQUEDIATRIZOATE SODIUM
003SOLUTION;ORAL, RECTAL40%0HYPAQUEDIATRIZOATE SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1956-03-26STANDARD
LABELING; LabelingSUPPL11AP1976-09-29
LABELING; LabelingSUPPL13AP1977-12-13
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1979-07-05STANDARD
LABELING; LabelingSUPPL15AP1984-01-12
LABELING; LabelingSUPPL16AP1982-06-30
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1991-05-29STANDARD
LABELING; LabelingSUPPL21AP1984-09-12
LABELING; LabelingSUPPL22AP1984-12-28
LABELING; LabelingSUPPL23AP1986-02-10
LABELING; LabelingSUPPL24AP1986-03-17
MANUF (CMC); Manufacturing (CMC)SUPPL25AP1986-08-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL26AP1988-08-02STANDARD
LABELING; LabelingSUPPL27AP1988-05-09
MANUF (CMC); Manufacturing (CMC)SUPPL28AP1990-08-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL29AP1990-08-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL31AP1993-10-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL32AP1996-08-23STANDARD
LABELING; LabelingSUPPL33AP1995-06-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL34AP1994-09-30STANDARD

Submissions Property Types

SUPPL14Null0
SUPPL19Null0
SUPPL25Null0
SUPPL26Null0
SUPPL28Null0
SUPPL29Null0
SUPPL31Null0
SUPPL32Null0
SUPPL34Null0

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11386
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYPAQUE","activeIngredients":"DIATRIZOATE SODIUM","strength":"100%","dosageForm":"FOR SOLUTION;ORAL, RECTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYPAQUE","activeIngredients":"DIATRIZOATE SODIUM","strength":"40%","dosageForm":"SOLUTION;ORAL, RECTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYPAQUE","submission":"DIATRIZOATE SODIUM","actionType":"100%","submissionClassification":"FOR SOLUTION;ORAL, RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYPAQUE","submission":"DIATRIZOATE SODIUM","actionType":"40%","submissionClassification":"SOLUTION;ORAL, RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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