ANNORA PHARMA FDA Approval ANDA 214467

ANDA 214467

ANNORA PHARMA

FDA Drug Application

Application #214467

Application Sponsors

ANDA 214467ANNORA PHARMA

Marketing Status

None (Tentative Approval)001

Application Products

001SOLUTION;ORAL1MG/ML0ENALAPRIL MALEATEENALAPRIL MALEATE

FDA Submissions

UNKNOWN; ORIG1TA2021-04-29STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ANNORA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214467
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/29\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-29
        )

)

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