ANDA 215982

JIANGSU HENGRUI MED

FDA Drug Application

Application #215982

Application Sponsors

ANDA 215982

JIANGSU HENGRUI MED

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

37.69GM/100ML (376.9MG/ML)

0

GADOTERATE MEGLUMINE

GADOTERATE MEGLUMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-04-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

JIANGSU HENGRUI MED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215982
            [companyName] => JIANGSU HENGRUI MED
            [docInserts] => ["",""]
            [products] => [{"drugName":"GADOTERATE MEGLUMINE","activeIngredients":"GADOTERATE MEGLUMINE","strength":"37.69GM\/100ML (376.9MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GADOTERATE MEGLUMINE","submission":"GADOTERATE MEGLUMINE","actionType":"37.69GM\/100ML (376.9MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)