ANDA 213053

ALEOR DERMACEUTICALS

FDA Drug Application

Application #213053

Documents

• Letter: 2021-12-20

Application Sponsors

ANDA 213053

ALEOR DERMACEUTICALS

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

EQ 2% BASE

0

MUPIROCIN

MUPIROCIN CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-11-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ALEOR DERMACEUTICALS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213053
            [companyName] => ALEOR DERMACEUTICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MUPIROCIN","activeIngredients":"MUPIROCIN CALCIUM","strength":"EQ 2% BASE","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/16\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-16
        )

)