XIROMED FDA Approval ANDA 213601

ANDA 213601

XIROMED

FDA Drug Application

Application #213601

Application Sponsors

ANDA 213601XIROMED

Marketing Status

Prescription001

Application Products

001AEROSOL, FOAM;TOPICAL2%0KETOCONAZOLEKETOCONAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2021-05-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAT

CDER Filings

XIROMED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213601
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOCONAZOLE","activeIngredients":"KETOCONAZOLE","strength":"2%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-21
        )

)

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