ANDA 203448

LUPIN LTD

FDA Drug Application

Application #203448

Application Sponsors

ANDA 203448

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET, CHEWABLE;ORAL

0.025MG;0.8MG

0

KAITLIB FE

ETHINYL ESTRADIOL; NORETHINDRONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-12-17

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203448
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"KAITLIB FE","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.025MG;0.8MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/17\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-17
        )

)