ANDA 208154

TELIGENT PHARMA INC

FDA Drug Application

Application #208154

Documents

• Letter: 2017-07-21

Application Sponsors

ANDA 208154

TELIGENT PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

2%

0

ERYTHROMYCIN

ERYTHROMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-07-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

TELIGENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208154
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERYTHROMYCIN","activeIngredients":"ERYTHROMYCIN","strength":"2%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208154Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-19
        )

)