ANDA 211851

PERRIGO PHARMA INTL

FDA Drug Application

Application #211851

Application Sponsors

ANDA 211851

PERRIGO PHARMA INTL

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

10%

0

EFINACONAZOLE

EFINACONAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-12-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

PERRIGO PHARMA INTL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211851
            [companyName] => PERRIGO PHARMA INTL
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFINACONAZOLE","activeIngredients":"EFINACONAZOLE","strength":"10%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-16
        )

)