ALEOR DERMACEUTICALS FDA Approval ANDA 214185

ANDA 214185

ALEOR DERMACEUTICALS

FDA Drug Application

Application #214185

Application Sponsors

ANDA 214185ALEOR DERMACEUTICALS

Marketing Status

Prescription001

Application Products

001GEL;TOPICAL0.3%;2.5%0ADAPALENE AND BENZOYL PEROXIDEADAPALENE; BENZOYL PEROXIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-04STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

ALEOR DERMACEUTICALS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214185
            [companyName] => ALEOR DERMACEUTICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADAPALENE AND BENZOYL PEROXIDE","activeIngredients":"ADAPALENE; BENZOYL PEROXIDE","strength":"0.3%;2.5%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ADAPALENE AND BENZOYL PEROXIDE","submission":"ADAPALENE; BENZOYL PEROXIDE","actionType":"0.3%;2.5%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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