JIANGSU HENGRUI MED FDA Approval ANDA 215304

ANDA 215304

JIANGSU HENGRUI MED

FDA Drug Application

Application #215304

Application Sponsors

ANDA 215304JIANGSU HENGRUI MED

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001SOLUTION;INTRAVENOUS1.8845GM/5ML (376.9MG/ML)0GADOTERATE MEGLUMINEGADOTERATE MEGLUMINE
002SOLUTION;INTRAVENOUS3.769GM/10ML (376.9MG/ML)0GADOTERATE MEGLUMINEGADOTERATE MEGLUMINE
003SOLUTION;INTRAVENOUS5.6535GM/15ML (376.9MG/ML)0GADOTERATE MEGLUMINEGADOTERATE MEGLUMINE
004SOLUTION;INTRAVENOUS7.538GM/20ML (376.9MG/ML)0GADOTERATE MEGLUMINEGADOTERATE MEGLUMINE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
004PrescriptionAP

CDER Filings

JIANGSU HENGRUI MED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215304
            [companyName] => JIANGSU HENGRUI MED
            [docInserts] => ["",""]
            [products] => [{"drugName":"GADOTERATE MEGLUMINE","activeIngredients":"GADOTERATE MEGLUMINE","strength":"1.8845GM\/5ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GADOTERATE MEGLUMINE","activeIngredients":"GADOTERATE MEGLUMINE","strength":"3.769GM\/10ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GADOTERATE MEGLUMINE","activeIngredients":"GADOTERATE MEGLUMINE","strength":"5.6535GM\/15ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GADOTERATE MEGLUMINE","activeIngredients":"GADOTERATE MEGLUMINE","strength":"7.538GM\/20ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-11
        )

)

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