MSN FDA Approval ANDA 212544

ANDA 212544

MSN

FDA Drug Application

Application #212544

Application Sponsors

ANDA 212544MSN

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORALEQ 30MG BASE0OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE
002CAPSULE;ORALEQ 45MG BASE0OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE
003CAPSULE;ORALEQ 75MG BASE0OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1AP2020-05-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

MSN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212544
            [companyName] => MSN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 30MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 45MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-20
        )

)

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