ANDA 207044

GLENMARK PHARMS LTD

FDA Drug Application

Application #207044

Application Sponsors

ANDA 207044

GLENMARK PHARMS LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

1.5MG

0

LEVONORGESTREL

LEVONORGESTREL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-03-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207044
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL","activeIngredients":"LEVONORGESTREL","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/25\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-25
        )

)