ANDA 205943

LUPIN LTD

FDA Drug Application

Application #205943

Application Sponsors

ANDA 205943

LUPIN LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A

0

FAYOSIM

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-03-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205943
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FAYOSIM","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N\/A","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-29
        )

)