GUERBET FDA Approval NDA 204781

NDA 204781

GUERBET

FDA Drug Application

Application #204781

Documents

Label2013-03-26
Letter2013-03-22
Review2013-05-10
Summary Review2013-05-10
Label2017-08-28
Letter2017-08-28
Label2017-09-15
Letter2017-09-19
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2018-04-27
Letter2018-05-01
Label2018-11-06
Medication Guide2018-11-06
Letter2018-11-15
Letter2019-07-24
Label2019-07-25
Medication Guide2019-07-25
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Statistical Review1900-01-01

Application Sponsors

NDA 204781GUERBET

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001SOLUTION;INTRAVENOUS37.69GM/100ML (376.9MG/ML)1DOTAREMGADOTERATE MEGLUMINE
002SOLUTION;INTRAVENOUS3.769GM/10ML (376.9MG/ML)1DOTAREMGADOTERATE MEGLUMINE
003SOLUTION;INTRAVENOUS5.6535GM/15ML (376.9MG/ML)1DOTAREMGADOTERATE MEGLUMINE
004SOLUTION;INTRAVENOUS7.538GM/20ML (376.9MG/ML)1DOTAREMGADOTERATE MEGLUMINE
005SOLUTION;INTRAVENOUS1.8845GM/5ML (376.9MG/ML)1DOTAREMGADOTERATE MEGLUMINE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2013-03-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2017-03-31N/A
LABELING; LabelingSUPPL5AP2017-09-14STANDARD
LABELING; LabelingSUPPL8AP2018-04-26STANDARD
LABELING; LabelingSUPPL9AP2018-11-02STANDARD
LABELING; LabelingSUPPL12AP2019-07-23STANDARD

Submissions Property Types

ORIG1Null15
SUPPL5Null6
SUPPL8Null15
SUPPL9Null6
SUPPL12Null7

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
004PrescriptionAP
005PrescriptionAP

CDER Filings

GUERBET
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204781
            [companyName] => GUERBET
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/204781s012lbl.pdf#page=17"]
            [products] => [{"drugName":"DOTAREM","activeIngredients":"GADOTERATE MEGLUMINE","strength":"37.69GM\/100ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DOTAREM","activeIngredients":"GADOTERATE MEGLUMINE","strength":"3.769GM\/10ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DOTAREM","activeIngredients":"GADOTERATE MEGLUMINE","strength":"5.6535GM\/15ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DOTAREM","activeIngredients":"GADOTERATE MEGLUMINE","strength":"7.538GM\/20ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DOTAREM","activeIngredients":"GADOTERATE MEGLUMINE","strength":"1.8845GM\/5ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/23\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204781s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204781s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204781s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204781s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204781s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2017","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204781s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204781s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/20\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204781s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204781Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204781Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204781Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/23\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204781s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204781Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"11\/02\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204781s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204781Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"04\/26\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204781s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204781Orig1s008Ltr.pdf\"}]","notes":">"},{"actionDate":"09\/14\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204781s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204781Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"03\/31\/2017","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/25\/2017","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204781s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204781Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-07-23
        )

)
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