GE HEALTHCARE FDA Approval NDA 020808

NDA 020808

GE HEALTHCARE

FDA Drug Application

Application #020808

Documents

Letter2015-07-10
Letter2003-09-25
Letter2003-12-23
Label2003-12-29
Label2015-07-09
Review2004-06-30
Label2017-04-07
Label2017-04-07
Letter2017-04-12
Letter2017-04-12
Label2019-03-13
Letter2019-03-14
Review2019-06-03
Label2022-02-24

Application Sponsors

NDA 020808GE HEALTHCARE

Marketing Status

Discontinued001
Prescription002

Application Products

001INJECTABLE;INJECTION55%0VISIPAQUE 270IODIXANOL
002INJECTABLE;INJECTION65.2%0VISIPAQUE 320IODIXANOL

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1997-08-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2003-09-04STANDARD
LABELING; LabelingSUPPL4AP2003-12-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2013-01-18STANDARD
LABELING; LabelingSUPPL24AP2015-07-06STANDARD
EFFICACY; EfficacySUPPL25AP2017-04-05PRIORITY
LABELING; LabelingSUPPL26AP2017-04-05STANDARD
LABELING; LabelingSUPPL28AP2019-03-12STANDARD
LABELING; LabelingSUPPL32AP2022-02-18STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL20Null0
SUPPL24Null6
SUPPL25Null7
SUPPL26Null7
SUPPL28Null7
SUPPL32Null15

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20808
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"VISIPAQUE 270","activeIngredients":"IODIXANOL","strength":"55%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VISIPAQUE 320","activeIngredients":"IODIXANOL","strength":"65.2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/12\/2019","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020351s048,020808s028lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020808s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-25","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020808s025lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2015","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020351s043,020808s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2003","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20808slr004_visipaque_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VISIPAQUE 270","submission":"IODIXANOL","actionType":"55%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VISIPAQUE 320","submission":"IODIXANOL","actionType":"65.2%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2019-03-12
        )

)

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