GE HEALTHCARE FDA Approval NDA 020608

NDA 020608

GE HEALTHCARE

FDA Drug Application

Application #020608

Documents

Letter2007-10-04
Label2015-07-09
Letter2004-03-10
Letter2004-03-03
Letter2015-07-10
Label2016-12-21
Letter2016-12-23
Label2017-04-07
Label2017-04-07
Letter2017-04-12
Letter2017-11-13
Label2017-11-14
Letter2022-02-22
Label2022-02-25

Application Sponsors

NDA 020608GE HEALTHCARE

Marketing Status

Discontinued001
Prescription002
Prescription003

Application Products

001SOLUTION;INJECTION, ORAL, RECTAL51.8%0OMNIPAQUE 240IOHEXOL
002SOLUTION;INJECTION, ORAL, RECTAL64.7%0OMNIPAQUE 300IOHEXOL
003SOLUTION;INJECTION, ORAL75.5%0OMNIPAQUE 350IOHEXOL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1995-10-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1997-06-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2000-12-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2002-08-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2002-11-20STANDARD
LABELING; LabelingSUPPL9AP2004-03-05STANDARD
LABELING; LabelingSUPPL10AP2004-02-13STANDARD
LABELING; LabelingSUPPL18AP2007-10-01STANDARD
LABELING; LabelingSUPPL31AP2015-07-06STANDARD
LABELING; LabelingSUPPL34AP2016-12-21STANDARD
LABELING; LabelingSUPPL36AP2017-04-05STANDARD
LABELING; LabelingSUPPL37AP2017-04-05STANDARD
LABELING; LabelingSUPPL38AP2017-11-09STANDARD
LABELING; LabelingSUPPL45AP2022-02-18STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL31Null6
SUPPL34Null6
SUPPL36Null15
SUPPL37Null6
SUPPL38Null6
SUPPL45Null7

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20608
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMNIPAQUE 240","activeIngredients":"IOHEXOL","strength":"51.8%","dosageForm":"SOLUTION;INJECTION, ORAL, RECTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OMNIPAQUE 300","activeIngredients":"IOHEXOL","strength":"64.7%","dosageForm":"SOLUTION;INJECTION, ORAL, RECTAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"OMNIPAQUE 350","activeIngredients":"IOHEXOL","strength":"75.5%","dosageForm":"SOLUTION;INJECTION, ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/09\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020608s038lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020608s038lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020608s037lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020608s036lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2016","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020608s034lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2015","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018956s095,020608s031lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OMNIPAQUE 240","submission":"IOHEXOL","actionType":"51.8%","submissionClassification":"SOLUTION;INJECTION, ORAL, RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OMNIPAQUE 300","submission":"IOHEXOL","actionType":"64.7%","submissionClassification":"SOLUTION;INJECTION, ORAL, RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OMNIPAQUE 350","submission":"IOHEXOL","actionType":"75.5%","submissionClassification":"SOLUTION;INJECTION, ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2017-11-09
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.