ANDA 212256

AMNEAL

FDA Drug Application

Application #212256

Application Sponsors

ANDA 212256

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

5%

0

TAVABOROLE

TAVABOROLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-11-25

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212256
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAVABOROLE","activeIngredients":"TAVABOROLE","strength":"5%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-25
        )

)