ANNORA PHARMA FDA Approval ANDA 215139

ANDA 215139

ANNORA PHARMA

FDA Drug Application

Application #215139

Application Sponsors

ANDA 215139ANNORA PHARMA

Marketing Status

None (Tentative Approval)001

Application Products

001LIQUID;ORAL1.1G/ML0GLYCEROL PHENYLBUTYRATEGLYCEROL PHENYLBUTYRATE

FDA Submissions

UNKNOWN; ORIG1TA2022-08-09STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ANNORA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215139
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCEROL PHENYLBUTYRATE","activeIngredients":"GLYCEROL PHENYLBUTYRATE","strength":"1.1G\/ML","dosageForm":"LIQUID;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/09\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-09
        )

)

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