TELIGENT PHARMA INC FDA Approval ANDA 208100

ANDA 208100

TELIGENT PHARMA INC

FDA Drug Application

Application #208100

Application Sponsors

ANDA 208100TELIGENT PHARMA INC

Marketing Status

Prescription001

Application Products

001SOLUTION;TOPICAL2%0ERYTHROMYCINERYTHROMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2017-11-20STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAT

CDER Filings

TELIGENT PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208100
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERYTHROMYCIN","activeIngredients":"ERYTHROMYCIN","strength":"2%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-20
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.