APTAPHARMA INC FDA Approval ANDA 212858

ANDA 212858

APTAPHARMA INC

FDA Drug Application

Application #212858

Application Sponsors

ANDA 212858APTAPHARMA INC

Marketing Status

Prescription001

Application Products

001FOR SUSPENSION;ORALEQ 6MG BASE/ML0OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-30STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB

CDER Filings

APTAPHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212858
            [companyName] => APTAPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 6MG BASE\/ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/30\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-30
        )

)

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