ANDA 211297

ENCUBE ETHICALS

FDA Drug Application

Application #211297

Documents

• Letter: 2020-08-26

Application Sponsors

ANDA 211297

ENCUBE ETHICALS

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;TOPICAL

5%

0

TAVABOROLE

TAVABOROLE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-07-20

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

ENCUBE ETHICALS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211297
            [companyName] => ENCUBE ETHICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAVABOROLE","activeIngredients":"TAVABOROLE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/20\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-20
        )

)