ANDA 211410

TELIGENT PHARMA INC

FDA Drug Application

Application #211410

Application Sponsors

ANDA 211410

TELIGENT PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.05%

0

FLUOCINONIDE

FLUOCINONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB1

CDER Filings

TELIGENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211410
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINONIDE","activeIngredients":"FLUOCINONIDE","strength":"0.05%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-16
        )

)