ANDA 209556

TELIGENT PHARMA INC

FDA Drug Application

Application #209556

Documents

• Letter: 2017-12-18

Application Sponsors

ANDA 209556

TELIGENT PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.1%

0

HYDROCORTISONE BUTYRATE

HYDROCORTISONE BUTYRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-11-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

TELIGENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209556
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE BUTYRATE","activeIngredients":"HYDROCORTISONE BUTYRATE","strength":"0.1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209556Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-21
        )

)