ACRUX DDS PTY FDA Approval ANDA 212482

ANDA 212482

ACRUX DDS PTY

FDA Drug Application

Application #212482

Application Sponsors

ANDA 212482ACRUX DDS PTY

Marketing Status

Prescription001

Application Products

001CREAM;TOPICAL2.5%;2.5%0LIDOCAINE AND PRILOCAINELIDOCAINE; PRILOCAINE

FDA Submissions

UNKNOWN; ORIG1AP2021-07-27STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

ACRUX DDS PTY
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212482
            [companyName] => ACRUX DDS PTY
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE AND PRILOCAINE","activeIngredients":"LIDOCAINE; PRILOCAINE","strength":"2.5%;2.5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/27\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-27
        )

)

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