STRIDES PHARMA FDA Approval ANDA 216046

ANDA 216046

STRIDES PHARMA

FDA Drug Application

Application #216046

Application Sponsors

ANDA 216046STRIDES PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL25MG0CYCLOSPORINECYCLOSPORINE
002CAPSULE;ORAL50MG0CYCLOSPORINECYCLOSPORINE
003CAPSULE;ORAL100MG0CYCLOSPORINECYCLOSPORINE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-02STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB1
002PrescriptionAB1
003PrescriptionAB1

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216046
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-02
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.