ANDA 212169

LUPIN LTD

FDA Drug Application

Application #212169

Application Sponsors

ANDA 212169

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;TOPICAL

10%

0

EFINACONAZOLE

EFINACONAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-12-22

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212169
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFINACONAZOLE","activeIngredients":"EFINACONAZOLE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/22\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-22
        )

)