ANDA 205278

MYLAN LABS LTD

FDA Drug Application

Application #205278

Application Sponsors

ANDA 205278

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

NORETHINDRONE ACETATE

NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-11-10

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205278
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE ACETATE","activeIngredients":"NORETHINDRONE ACETATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/10\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-10
        )

)