ANDA 208848

TELIGENT PHARMA INC

FDA Drug Application

Application #208848

Application Sponsors

ANDA 208848

TELIGENT PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.1%

0

TRIAMCINOLONE ACETONIDE

TRIAMCINOLONE ACETONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-09-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

TELIGENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208848
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/18\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/29\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-01-29
        )

)