AJANTA PHARMA LTD FDA Approval ANDA 212784

ANDA 212784

AJANTA PHARMA LTD

FDA Drug Application

Application #212784

Application Sponsors

ANDA 212784AJANTA PHARMA LTD

Marketing Status

Prescription001

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2020-05-27STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

AJANTA PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212784
            [companyName] => AJANTA PHARMA LTD
            [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":"05\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-27
        )

)

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