GE HEALTHCARE FDA Approval NDA 020123

NDA 020123

GE HEALTHCARE

FDA Drug Application

Application #020123

Documents

Letter2002-07-08
Letter2010-12-22
Letter2013-08-29
Letter2014-11-18
Label2007-12-27
Label2010-12-20
Label2013-08-28
Review1997-10-03
Letter2002-05-17
Letter2002-06-28
Letter2003-07-31
Letter2007-09-07
Letter2008-01-09
Other Important Information from FDA2006-06-09
Label2007-09-06
Label2014-11-20
Label2018-04-27
Medication Guide2018-04-27
Letter2018-05-01
Label2018-11-06
Letter2018-11-08

Application Sponsors

NDA 020123GE HEALTHCARE

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION287MG/ML1OMNISCANGADODIAMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1993-01-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1994-11-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1994-06-06STANDARD
EFFICACY; EfficacySUPPL4AP1996-02-05UNKNOWN
EFFICACY; EfficacySUPPL5AP1996-02-05STANDARD
EFFICACY; EfficacySUPPL7AP1996-02-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1995-02-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1997-03-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1997-03-19STANDARD
LABELING; LabelingSUPPL15AP1997-10-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2001-01-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2001-03-13STANDARD
LABELING; LabelingSUPPL18AP2002-07-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2001-07-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2002-03-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2002-05-20STANDARD
LABELING; LabelingSUPPL22AP2002-06-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2002-11-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2002-08-12STANDARD
LABELING; LabelingSUPPL34AP2007-09-05STANDARD
LABELING; LabelingSUPPL35AP2007-12-14STANDARD
LABELING; LabelingSUPPL37AP2010-12-20UNKNOWN
LABELING; LabelingSUPPL39AP2013-08-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL40AP2014-05-14N/A
MANUF (CMC); Manufacturing (CMC)SUPPL41AP2014-04-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL42AP2014-06-23STANDARD
LABELING; LabelingSUPPL43AP2014-11-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL44AP2016-06-06STANDARD
LABELING; LabelingSUPPL46AP2018-04-26STANDARD
LABELING; LabelingSUPPL47AP2018-11-07STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL9Null0
SUPPL13Null0
SUPPL14Null0
SUPPL16Null0
SUPPL17Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL23Null0
SUPPL24Null0
SUPPL37Null6
SUPPL39Null15
SUPPL40Null15
SUPPL41Null0
SUPPL42Null0
SUPPL43Null15
SUPPL44Null0
SUPPL46Null7
SUPPL47Null15

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20123
            [companyName] => GE HEALTHCARE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/020123s046lbl.pdf#page=1"]
            [products] => [{"drugName":"OMNISCAN","activeIngredients":"GADODIAMIDE","strength":"287MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/07\/2018","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020123s047,022066s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2018","submission":"SUPPL-46","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020123s046lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2014","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022066s007,020123s043lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2013","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022066s00420123s039lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2010","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020123s037lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2007","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020123s035lbl.pdf\"}]","notes":""},{"actionDate":"09\/05\/2007","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020123s034lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OMNISCAN","submission":"GADODIAMIDE","actionType":"287MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-11-07
        )

)

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