ACCORD HLTHCARE FDA Approval ANDA 206807

ANDA 206807

ACCORD HLTHCARE

FDA Drug Application

Application #206807

Application Sponsors

ANDA 206807ACCORD HLTHCARE

Marketing Status

Prescription001

Application Products

001TABLET;ORAL-280.35MG0NORETHINDRONENORETHINDRONE

FDA Submissions

UNKNOWN; ORIG1AP2016-12-13STANDARD
LABELING; LabelingSUPPL3AP2022-09-09STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null15

TE Codes

001PrescriptionAB1

CDER Filings

NAARI PTE LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206807
            [companyName] => NAARI PTE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE","activeIngredients":"NORETHINDRONE","strength":"0.35MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/13\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-12-13
        )

)

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