FLATWING FDA Approval ANDA 211963

ANDA 211963

FLATWING

FDA Drug Application

Application #211963

Application Sponsors

ANDA 211963FLATWING

Marketing Status

Prescription001

Application Products

001SOLUTION;TOPICAL5.0%0TAVABOROLETAVABOROLE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-03STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

FLATWING
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211963
            [companyName] => FLATWING
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAVABOROLE","activeIngredients":"TAVABOROLE","strength":"5.0%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/03\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-03
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.