HENGRUI PHARMA FDA Approval ANDA 215061

ANDA 215061

HENGRUI PHARMA

FDA Drug Application

Application #215061

Application Sponsors

ANDA 215061HENGRUI PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001SOLUTION;INTRAVENOUS1.20944GM/2ML (604.72MG/ML)0GADOBUTROLGADOBUTROL
002SOLUTION;INTRAVENOUS4.5354GM/7.5ML (604.72MG/ML)0GADOBUTROLGADOBUTROL
003SOLUTION;INTRAVENOUS6.0472GM/10ML (604.72MG/ML)0GADOBUTROLGADOBUTROL
004SOLUTION;INTRAVENOUS9.0708GM/15ML (604.72MG/ML)0GADOBUTROLGADOBUTROL

FDA Submissions

UNKNOWN; ORIG1AP2022-11-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
004PrescriptionAP

CDER Filings

HENGRUI PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215061
            [companyName] => HENGRUI PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"GADOBUTROL","activeIngredients":"GADOBUTROL","strength":"1.20944GM\/2ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GADOBUTROL","activeIngredients":"GADOBUTROL","strength":"4.5354GM\/7.5ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GADOBUTROL","activeIngredients":"GADOBUTROL","strength":"6.0472GM\/10ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GADOBUTROL","activeIngredients":"GADOBUTROL","strength":"9.0708GM\/15ML (604.72MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-17
        )

)

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