GLENMARK PHARMS LTD FDA Approval ANDA 209996

ANDA 209996

GLENMARK PHARMS LTD

FDA Drug Application

Application #209996

Application Sponsors

ANDA 209996GLENMARK PHARMS LTD

Marketing Status

Prescription001

Application Products

001OINTMENT;TOPICAL0.05%0DESONIDEDESONIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-09-15STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209996
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESONIDE","activeIngredients":"DESONIDE","strength":"0.05%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/15\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-09-15
        )

)

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