XIROMED FDA Approval ANDA 201501

ANDA 201501

XIROMED

FDA Drug Application

Application #201501

Application Sponsors

ANDA 201501XIROMED

Marketing Status

Prescription001

Application Products

001OINTMENT;TOPICAL5%0ACYCLOVIRACYCLOVIR

FDA Submissions

UNKNOWN; ORIG1AP2020-01-29STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

XIROMED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201501
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"5%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/29\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-29
        )

)

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