TELIGENT PHARMA INC FDA Approval ANDA 208667

ANDA 208667

TELIGENT PHARMA INC

FDA Drug Application

Application #208667

Application Sponsors

ANDA 208667TELIGENT PHARMA INC

Marketing Status

Prescription001

Application Products

001LOTION;TOPICAL0.05%0CLOBETASOL PROPIONATECLOBETASOL PROPIONATE

FDA Submissions

UNKNOWN; ORIG1AP2016-11-29STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

TELIGENT PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208667
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/06\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-06
        )

)

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