AET PHARMA FDA Approval ANDA 213454

ANDA 213454

AET PHARMA

FDA Drug Application

Application #213454

Application Sponsors

ANDA 213454AET PHARMA

Marketing Status

Prescription001

Application Products

001TABLET, DELAYED RELEASE;ORAL100MG0POSACONAZOLEPOSACONAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

AET PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213454
            [companyName] => AET PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POSACONAZOLE","activeIngredients":"POSACONAZOLE","strength":"100MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/01\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-01
        )

)

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