MAYNE PHARMA FDA Approval ANDA 076225

ANDA 076225

MAYNE PHARMA

FDA Drug Application

Application #076225

Application Sponsors

ANDA 076225MAYNE PHARMA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL-280.35MG0ERRINNORETHINDRONE

FDA Submissions

ORIG1AP2002-10-21
LABELING; LabelingSUPPL6AP2011-06-10
LABELING; LabelingSUPPL11AP2015-04-02STANDARD

Submissions Property Types

SUPPL6Null7
SUPPL11Null15

TE Codes

001PrescriptionAB2

CDER Filings

MAYNE PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76225
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERRIN","activeIngredients":"NORETHINDRONE","strength":"0.35MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ERRIN","submission":"NORETHINDRONE","actionType":"0.35MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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