ANDA 216074

LUPIN LTD

FDA Drug Application

Application #216074

Application Sponsors

ANDA 216074

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

002

TABLET; ORAL

150mg

0

IVACAFTOR

IVACAFTOR

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-06-07

STANDARD

Submissions Property Types

ORIG

1

Null

31

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
        )

)