ANNORA PHARMA FDA Approval ANDA 215420

ANDA 215420

ANNORA PHARMA

FDA Drug Application

Application #215420

Application Sponsors

ANDA 215420ANNORA PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001POWDER;ORAL100MG/PACKET0SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE
002POWDER;ORAL500MG/PACKET0SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-18STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ANNORA PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215420
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SAPROPTERIN DIHYDROCHLORIDE","activeIngredients":"SAPROPTERIN DIHYDROCHLORIDE","strength":"100MG\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SAPROPTERIN DIHYDROCHLORIDE","activeIngredients":"SAPROPTERIN DIHYDROCHLORIDE","strength":"500MG\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-18
        )

)

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