STRIDES PHARMA FDA Approval ANDA 211894

ANDA 211894

STRIDES PHARMA

FDA Drug Application

Application #211894

Application Sponsors

ANDA 211894STRIDES PHARMA

Marketing Status

Prescription001

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-01-13STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211894
            [companyName] => STRIDES PHARMA
            [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":"01\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-13
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.