GE HEALTHCARE FDA Approval NDA 017982

NDA 017982

GE HEALTHCARE

FDA Drug Application

Application #017982

Application Sponsors

NDA 017982GE HEALTHCARE

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001INJECTABLE;INJECTION3.75GM/VIAL0AMIPAQUEMETRIZAMIDE
002INJECTABLE;INJECTION6.75GM/VIAL0AMIPAQUEMETRIZAMIDE
003INJECTABLE;INJECTION2.5GM/VIAL0AMIPAQUEMETRIZAMIDE
004INJECTABLE;INJECTION13.5GM/VIAL0AMIPAQUEMETRIZAMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1978-08-23PRIORITY
LABELING; LabelingSUPPL2AP1980-02-29PRIORITY
LABELING; LabelingSUPPL5AP1980-02-29PRIORITY
EFFICACY; EfficacySUPPL6AP1983-01-17PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1981-11-18PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1981-10-02PRIORITY
LABELING; LabelingSUPPL11AP1982-07-09PRIORITY
EFFICACY; EfficacySUPPL17AP1983-09-12PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1983-01-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1983-09-12PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1988-05-23PRIORITY
LABELING; LabelingSUPPL22AP1987-08-04PRIORITY
LABELING; LabelingSUPPL23AP1986-11-20PRIORITY
LABELING; LabelingSUPPL24AP1989-05-31PRIORITY

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL11Null0
SUPPL17Null0
SUPPL18Null0
SUPPL19Null0
SUPPL21Null0
SUPPL22Null0
SUPPL23Null0
SUPPL24Null0

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17982
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMIPAQUE","activeIngredients":"METRIZAMIDE","strength":"3.75GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMIPAQUE","activeIngredients":"METRIZAMIDE","strength":"6.75GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMIPAQUE","activeIngredients":"METRIZAMIDE","strength":"2.5GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMIPAQUE","activeIngredients":"METRIZAMIDE","strength":"13.5GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMIPAQUE","submission":"METRIZAMIDE","actionType":"3.75GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMIPAQUE","submission":"METRIZAMIDE","actionType":"6.75GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMIPAQUE","submission":"METRIZAMIDE","actionType":"2.5GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMIPAQUE","submission":"METRIZAMIDE","actionType":"13.5GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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