JIANGSU PHARMS FDA Approval ANDA 214271

ANDA 214271

JIANGSU PHARMS

FDA Drug Application

Application #214271

Application Sponsors

ANDA 214271JIANGSU PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION55%0IODIXANOLIODIXANOL
002INJECTABLE;INJECTION65.2%0IODIXANOLIODIXANOL

FDA Submissions

UNKNOWN; ORIG1AP2022-05-19STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

JIANGSU PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214271
            [companyName] => JIANGSU PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"IODIXANOL","activeIngredients":"IODIXANOL","strength":"55%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IODIXANOL","activeIngredients":"IODIXANOL","strength":"65.2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-19
        )

)

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