ZYDUS PHARMS FDA Approval ANDA 210199

ANDA 210199

ZYDUS PHARMS

FDA Drug Application

Application #210199

Application Sponsors

ANDA 210199ZYDUS PHARMS

Marketing Status

Prescription001

Application Products

001OINTMENT;TOPICAL0.05%0CLOBETASOL PROPIONATECLOBETASOL PROPIONATE

FDA Submissions

UNKNOWN; ORIG1AP2017-10-27STANDARD
LABELING; LabelingSUPPL6AP2022-10-07STANDARD

Submissions Property Types

ORIG1Null15
SUPPL6Null7

TE Codes

001PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210199
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-27
        )

)

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