ANDA 203804

TELIGENT PHARMA INC

FDA Drug Application

Application #203804

Application Sponsors

ANDA 203804

TELIGENT PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

2.5%

0

HYDROCORTISONE

HYDROCORTISONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-07-27

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

TELIGENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203804
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"2.5%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-27
        )

)