EUGIA PHARMA SPECLTS FDA Approval ANDA 214842

ANDA 214842

EUGIA PHARMA SPECLTS

FDA Drug Application

Application #214842

Documents

Letter2022-08-30

Application Sponsors

ANDA 214842EUGIA PHARMA SPECLTS

Marketing Status

None (Tentative Approval)001

Application Products

001INJECTABLE;INJECTION300MG/16.7ML(18MG/ML)0POSACONAZOLEPOSACONAZOLE

FDA Submissions

UNKNOWN; ORIG1TA2022-07-28STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

EUGIA PHARMA SPECLTS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214842
            [companyName] => EUGIA PHARMA SPECLTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"POSACONAZOLE","activeIngredients":"POSACONAZOLE","strength":"300MG\/16.7ML(18MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/28\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-28
        )

)

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