ANDA 210016

GE HEALTHCARE

FDA Drug Application

Application #210016

Documents

• Letter: 2019-12-04

Application Sponsors

ANDA 210016

GE HEALTHCARE

Marketing Status

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

Application Products

001	SOLUTION;INTRAVENOUS	3.769GM/10ML (376.9MG/ML)	0	CLARISCAN	GADOTERATE MEGLUMINE
002	SOLUTION;INTRAVENOUS	5.6535GM/15ML (376.9MG/ML)	0	CLARISCAN	GADOTERATE MEGLUMINE
003	SOLUTION;INTRAVENOUS	7.538GM/20ML (376.9MG/ML)	0	CLARISCAN	GADOTERATE MEGLUMINE
004	SOLUTION;INTRAVENOUS	37.69GM/100ML (376.9MG/ML)	0	CLARISCAN	GADOTERATE MEGLUMINE
005	SOLUTION;INTRAVENOUS	1.8845GM/5ML (376.9MG/ML)	0	CLARISCAN	GADOTERATE MEGLUMINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-11-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-11-24	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP
005	Prescription	AP

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210016
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARISCAN","activeIngredients":"GADOTERATE MEGLUMINE","strength":"3.769GM\/10ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLARISCAN","activeIngredients":"GADOTERATE MEGLUMINE","strength":"5.6535GM\/15ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLARISCAN","activeIngredients":"GADOTERATE MEGLUMINE","strength":"7.538GM\/20ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLARISCAN","activeIngredients":"GADOTERATE MEGLUMINE","strength":"37.69GM\/100ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/01\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210016Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-01
        )

)