GE HEALTHCARE FDA Approval NDA 020899

NDA 020899

GE HEALTHCARE

FDA Drug Application

Application #020899

Documents

Letter2002-05-10
Letter2007-11-19
Letter2008-06-09
Label2007-10-04
Other Important Information from FDA2008-07-11
Letter2012-08-20
Label2008-06-12
Label2012-08-20
Label2016-09-16
Label2016-09-16
Letter2016-09-20
Letter2016-09-20
Letter2021-09-03
Letter2021-09-20
Label2021-09-20

Application Sponsors

NDA 020899GE HEALTHCARE

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION10MG/ML1OPTISONALBUMIN HUMAN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1997-12-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1999-02-01STANDARD
LABELING; LabelingSUPPL3AP2000-03-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2000-02-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1999-05-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2000-12-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-05-10STANDARD
LABELING; LabelingSUPPL10AP2007-11-08STANDARD
LABELING; LabelingSUPPL11AP2008-06-06STANDARD
EFFICACY; EfficacySUPPL15AP2012-08-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2013-11-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2016-04-15STANDARD
LABELING; LabelingSUPPL18AP2016-09-16STANDARD
LABELING; LabelingSUPPL19AP2016-09-16STANDARD
LABELING; LabelingSUPPL23TA2021-03-05STANDARD
LABELING; LabelingSUPPL24AP2021-09-16STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL15Null7
SUPPL16Null0
SUPPL17Null0
SUPPL18Null15
SUPPL19Null6
SUPPL23Null15
SUPPL24Null15

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20899
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"OPTISON","activeIngredients":"ALBUMIN HUMAN","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/16\/2016","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020899s018s019lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2016","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020899s018s019lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2012","submission":"SUPPL-15","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020899s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2008","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020899s011lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2002","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/020899s007lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"OPTISON","submission":"ALBUMIN HUMAN","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-09-16
        )

)

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