PADAGIS ISRAEL FDA Approval ANDA 212465

ANDA 212465

PADAGIS ISRAEL

FDA Drug Application

Application #212465

Application Sponsors

ANDA 212465PADAGIS ISRAEL

Marketing Status

Prescription001

Application Products

001CREAM;TOPICALEQ 2% BASE0MUPIROCINMUPIROCIN CALCIUM

FDA Submissions

UNKNOWN; ORIG1AP2022-08-03STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

PADAGIS ISRAEL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212465
            [companyName] => PADAGIS ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MUPIROCIN","activeIngredients":"MUPIROCIN CALCIUM","strength":"EQ 2% BASE","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-03
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.