ACRUX DDS FDA Approval ANDA 211969

ANDA 211969

ACRUX DDS

FDA Drug Application

Application #211969

Application Sponsors

ANDA 211969ACRUX DDS

Marketing Status

Prescription001

Application Products

001SOLUTION;TOPICAL10%0EFINACONAZOLEEFINACONAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-21STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB

CDER Filings

ACRUX DDS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211969
            [companyName] => ACRUX DDS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFINACONAZOLE","activeIngredients":"EFINACONAZOLE","strength":"10%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-21
        )

)

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