GUERBET FDA Approval NDA 216986

NDA 216986

GUERBET

FDA Drug Application

Application #216986

Documents

Label2022-09-21
Medication Guide2022-09-21
Letter2022-09-22
Review2022-10-20

Application Sponsors

NDA 216986GUERBET

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007

Application Products

001SOLUTION;INTRAVENOUS1.4553GM/3ML (485.1MG/ML)1ELUCIREMGADOPICLENOL
002SOLUTION;INTRAVENOUS3.63825GM/7.5ML (485.1MG/ML)1ELUCIREMGADOPICLENOL
003SOLUTION;INTRAVENOUS4.851GM/10ML (485.1MG/ML)1ELUCIREMGADOPICLENOL
004SOLUTION;INTRAVENOUS7.2765GM/15ML (485.1MG/ML)1ELUCIREMGADOPICLENOL
005SOLUTION;INTRAVENOUS14.553GM/30ML (485.1MG/ML)1ELUCIREMGADOPICLENOL
006SOLUTION;INTRAVENOUS24.255GM/50ML (485.1MG/ML)1ELUCIREMGADOPICLENOL
007SOLUTION;INTRAVENOUS48.51GM/100ML (485.1MG/ML)1ELUCIREMGADOPICLENOL

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG1AP2022-09-21PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

GUERBET
cder:Array
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    [0] => Array
        (
            [ApplNo] => 216986
            [companyName] => GUERBET
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/216986s000lbl.pdf#page=17"]
            [products] => [{"drugName":"ELUCIREM","activeIngredients":"GADOPICLENOL","strength":"1.4553GM\/3ML (485.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ELUCIREM","activeIngredients":"GADOPICLENOL","strength":"3.63825GM\/7.5ML (485.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ELUCIREM","activeIngredients":"GADOPICLENOL","strength":"4.851GM\/10ML (485.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ELUCIREM","activeIngredients":"GADOPICLENOL","strength":"7.2765GM\/15ML (485.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ELUCIREM","activeIngredients":"GADOPICLENOL","strength":"14.553GM\/30ML (485.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ELUCIREM","activeIngredients":"GADOPICLENOL","strength":"24.255GM\/50ML (485.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ELUCIREM","activeIngredients":"GADOPICLENOL","strength":"48.51GM\/100ML (485.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/21\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216986s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216986s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216986Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-09-21
        )

)

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