GE HEALTHCARE FDA Approval NDA 009561

NDA 009561

GE HEALTHCARE

FDA Drug Application

Application #009561

Application Sponsors

NDA 009561GE HEALTHCARE

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001INJECTABLE;INJECTION50%0HYPAQUEDIATRIZOATE SODIUM
002SOLUTION;URETERAL20%0HYPAQUE SODIUM 20%DIATRIZOATE SODIUM
003INJECTABLE;INJECTION25%0HYPAQUEDIATRIZOATE SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1954-11-26PRIORITY
LABELING; LabelingSUPPL22AP1976-02-11PRIORITY
LABELING; LabelingSUPPL23AP1976-06-02PRIORITY
LABELING; LabelingSUPPL24AP1976-05-26PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL25AP1976-09-08PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL26AP1976-06-02PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL27AP1976-05-26PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL30AP1976-09-08PRIORITY
LABELING; LabelingSUPPL31AP1977-02-23PRIORITY
LABELING; LabelingSUPPL33AP1978-10-06PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL34AP1977-12-16PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL35AP1978-01-31PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL36AP1978-02-01PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL37AP1979-02-15PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL38AP1979-01-22PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL39AP1979-10-11PRIORITY
LABELING; LabelingSUPPL40AP1982-06-30PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL41AP1981-04-11PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL42AP1986-08-06PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL43AP1982-01-18PRIORITY
LABELING; LabelingSUPPL45AP1984-02-29PRIORITY
LABELING; LabelingSUPPL46AP1984-04-05PRIORITY
LABELING; LabelingSUPPL47AP1982-02-24PRIORITY
LABELING; LabelingSUPPL48AP1987-02-01PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL49AP1982-03-18PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL50AP1983-08-03PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL52AP1982-10-18PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL53AP1985-01-14PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL55AP1987-03-23PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL56AP1988-05-23PRIORITY
LABELING; LabelingSUPPL57AP1985-04-19PRIORITY
LABELING; LabelingSUPPL58AP1985-06-26PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL59AP1986-08-14PRIORITY
LABELING; LabelingSUPPL60AP1986-03-17PRIORITY
LABELING; LabelingSUPPL61AP1986-06-25PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL62AP1990-02-26PRIORITY
LABELING; LabelingSUPPL63AP1986-11-07PRIORITY
LABELING; LabelingSUPPL64AP1987-08-24PRIORITY
LABELING; LabelingSUPPL66AP1988-02-22PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL67AP1989-04-11PRIORITY
LABELING; LabelingSUPPL68AP1989-05-02PRIORITY
LABELING; LabelingSUPPL69AP1989-05-26PRIORITY
LABELING; LabelingSUPPL70AP1989-06-29PRIORITY
LABELING; LabelingSUPPL71AP1991-10-03PRIORITY
LABELING; LabelingSUPPL72AP1991-10-03PRIORITY
LABELING; LabelingSUPPL73AP1991-10-03PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL75AP1993-10-05PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL76AP1996-08-23PRIORITY
LABELING; LabelingSUPPL77AP1995-06-15PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL78AP1998-08-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL79AP2001-08-13PRIORITY

Submissions Property Types

ORIG1Null0
SUPPL22Null0
SUPPL23Null0
SUPPL24Null0
SUPPL25Null0
SUPPL26Null0
SUPPL27Null0
SUPPL30Null0
SUPPL31Null0
SUPPL33Null0
SUPPL34Null0
SUPPL35Null0
SUPPL36Null0
SUPPL37Null0
SUPPL38Null0
SUPPL39Null0
SUPPL40Null0
SUPPL41Null0
SUPPL42Null0
SUPPL43Null0
SUPPL45Null0
SUPPL46Null0
SUPPL47Null0
SUPPL48Null0
SUPPL49Null0
SUPPL50Null0
SUPPL52Null0
SUPPL53Null0
SUPPL55Null0
SUPPL56Null0
SUPPL57Null0
SUPPL58Null0
SUPPL59Null0
SUPPL60Null0
SUPPL61Null0
SUPPL62Null0
SUPPL63Null0
SUPPL64Null0
SUPPL66Null0
SUPPL67Null0
SUPPL68Null0
SUPPL69Null0
SUPPL70Null0
SUPPL71Null0
SUPPL72Null0
SUPPL73Null0
SUPPL75Null0
SUPPL76Null0
SUPPL77Null0
SUPPL78Null0
SUPPL79Null0

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 9561
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYPAQUE","activeIngredients":"DIATRIZOATE SODIUM","strength":"50%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYPAQUE","activeIngredients":"DIATRIZOATE SODIUM","strength":"25%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYPAQUE SODIUM 20%","activeIngredients":"DIATRIZOATE SODIUM","strength":"20%","dosageForm":"SOLUTION;URETERAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYPAQUE","submission":"DIATRIZOATE SODIUM","actionType":"50%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYPAQUE","submission":"DIATRIZOATE SODIUM","actionType":"25%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYPAQUE SODIUM 20%","submission":"DIATRIZOATE SODIUM","actionType":"20%","submissionClassification":"SOLUTION;URETERAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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