ANDA 216936

LUPIN LTD

FDA Drug Application

Application #216936

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 216936

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

4MG

0

DROSPIRENONE

DROSPIRENONE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-11-03

UNKNOWN

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216936
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROSPIRENONE","activeIngredients":"DROSPIRENONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/03\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-03
        )

)