ANNORA PHARMA FDA Approval ANDA 212239

ANDA 212239

ANNORA PHARMA

FDA Drug Application

Application #212239

Application Sponsors

ANDA 212239ANNORA PHARMA

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL10MG/ML0ITRACONAZOLEITRACONAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

ANNORA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212239
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ITRACONAZOLE","activeIngredients":"ITRACONAZOLE","strength":"10MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-01
        )

)

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