MYLAN FDA Approval ANDA 205894

ANDA 205894

MYLAN

FDA Drug Application

Application #205894

Documents

Letter2022-02-04

Application Sponsors

ANDA 205894MYLAN

Marketing Status

Prescription001

Application Products

001EMULSION;OPHTHALMIC0.05%0CYCLOSPORINECYCLOSPORINE

FDA Submissions

UNKNOWN; ORIG1AP2022-02-02STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205894
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"0.05%","dosageForm":"EMULSION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/205894Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-02
        )

)

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