LUPIN LTD FDA Approval ANDA 204130

ANDA 204130

LUPIN LTD

FDA Drug Application

Application #204130

Application Sponsors

ANDA 204130LUPIN LTD

Marketing Status

None (Tentative Approval)001

Application Products

001TABLET;ORAL700MG0FOSAMPRENAVIR CALCIUMFOSAMPRENAVIR CALCIUM

FDA Submissions

UNKNOWN; ORIG1TA2016-07-25

Submissions Property Types

ORIG1Null17

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
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.