NDA 216986

GUERBET

FDA Drug Application

Application #216986

Documents

• Label: 2022-09-21
• Medication Guide: 2022-09-21
• Letter: 2022-09-22
• Review: 2022-10-20

Application Sponsors

NDA 216986

GUERBET

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	SOLUTION;INTRAVENOUS	1.4553GM/3ML (485.1MG/ML)	1	ELUCIREM	GADOPICLENOL
002	SOLUTION;INTRAVENOUS	3.63825GM/7.5ML (485.1MG/ML)	1	ELUCIREM	GADOPICLENOL
003	SOLUTION;INTRAVENOUS	4.851GM/10ML (485.1MG/ML)	1	ELUCIREM	GADOPICLENOL
004	SOLUTION;INTRAVENOUS	7.2765GM/15ML (485.1MG/ML)	1	ELUCIREM	GADOPICLENOL
005	SOLUTION;INTRAVENOUS	14.553GM/30ML (485.1MG/ML)	1	ELUCIREM	GADOPICLENOL
006	SOLUTION;INTRAVENOUS	24.255GM/50ML (485.1MG/ML)	1	ELUCIREM	GADOPICLENOL
007	SOLUTION;INTRAVENOUS	48.51GM/100ML (485.1MG/ML)	1	ELUCIREM	GADOPICLENOL

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination

ORIG

1

AP

2022-09-21

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

GUERBET

cder:Array
(
    [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
        )

)