MYLAN FDA Approval ANDA 213847

ANDA 213847

MYLAN

FDA Drug Application

Application #213847

Application Sponsors

ANDA 213847MYLAN

Marketing Status

Prescription001

Application Products

001GEL;TOPICAL7.5%0DAPSONEDAPSONE

FDA Submissions

UNKNOWN; ORIG1AP2022-02-04STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213847
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPSONE","activeIngredients":"DAPSONE","strength":"7.5%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/04\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-04
        )

)

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