LUPIN LTD FDA Approval ANDA 216074

ANDA 216074

LUPIN LTD

FDA Drug Application

Application #216074

Application Sponsors

ANDA 216074LUPIN LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

002TABLET; ORAL150mg0IVACAFTORIVACAFTOR

FDA Submissions

UNKNOWN; ORIG1TA2022-06-07STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216074
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IVACAFTOR","activeIngredients":"IVACAFTOR","strength":"75mg","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"IVACAFTOR","activeIngredients":"IVACAFTOR","strength":"150mg","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/07\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-07
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.