ANDA 212188

ALEOR DERMACEUTICALS

FDA Drug Application

Application #212188

Documents

• Letter: 2020-09-18

Application Sponsors

ANDA 212188

ALEOR DERMACEUTICALS

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;TOPICAL

5%

0

TAVABOROLE

TAVABOROLE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-08-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

ALEOR DERMACEUTICALS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212188
            [companyName] => ALEOR DERMACEUTICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAVABOROLE","activeIngredients":"TAVABOROLE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/12\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-12
        )

)