ANDA 204130

LUPIN LTD

FDA Drug Application

Application #204130

Application Sponsors

ANDA 204130

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

700MG

0

FOSAMPRENAVIR CALCIUM

FOSAMPRENAVIR CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-07-25

Submissions Property Types

ORIG

1

Null

17

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204130
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSAMPRENAVIR CALCIUM","activeIngredients":"FOSAMPRENAVIR CALCIUM","strength":"700MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/25\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-07-25
        )

)