ANDA 212066

AUROBINDO PHARMA LTD

FDA Drug Application

Application #212066

Application Sponsors

ANDA 212066

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

10%

0

EFINACONAZOLE

EFINACONAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-03-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212066
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFINACONAZOLE","activeIngredients":"EFINACONAZOLE","strength":"10%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/29\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-29
        )

)