VISTAPHARM FDA Approval ANDA 065422

ANDA 065422

VISTAPHARM

FDA Drug Application

Application #065422

Application Sponsors

ANDA 065422VISTAPHARM

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL100,000 UNITS/ML0NYSTATINNYSTATIN

FDA Submissions

ORIG1AP2011-03-07

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

VISTAPHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65422
            [companyName] => VISTAPHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"NYSTATIN","activeIngredients":"NYSTATIN","strength":"100,000 UNITS\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NYSTATIN","submission":"NYSTATIN","actionType":"100,000 UNITS\/ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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