ANDA 202740

MYLAN LABS LTD

FDA Drug Application

Application #202740

Application Sponsors

ANDA 202740

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.75MG

0

LEVONORGESTREL

LEVONORGESTREL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-09-02

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Over-the-counter

AB

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202740
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL","activeIngredients":"LEVONORGESTREL","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/02\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-09-02
        )

)