APOTEX FDA Approval ANDA 207606

ANDA 207606

APOTEX

FDA Drug Application

Application #207606

Application Sponsors

ANDA 207606APOTEX

Marketing Status

Prescription001

Application Products

001EMULSION;OPHTHALMIC0.05%0CYCLOSPORINECYCLOSPORINE

FDA Submissions

UNKNOWN; ORIG1AP2023-01-12STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207606
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"0.05%","dosageForm":"EMULSION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/12\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-12
        )

)

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