ANDA 205033

PERRIGO UK FINCO

FDA Drug Application

Application #205033

Application Sponsors

ANDA 205033

PERRIGO UK FINCO

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.1%;2.5%

0

ADAPALENE AND BENZOYL PEROXIDE

ADAPALENE; BENZOYL PEROXIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-01-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO UK FINCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205033
            [companyName] => PERRIGO UK FINCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADAPALENE AND BENZOYL PEROXIDE","activeIngredients":"ADAPALENE; BENZOYL PEROXIDE","strength":"0.1%;2.5%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-01-23
        )

)