ANDA 065108

XGEN PHARMS

FDA Drug Application

Application #065108

Application Sponsors

ANDA 065108

XGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;IRRIGATION

EQ 40MG BASE/ML;200,000 UNITS/ML

0

NEOMYCIN AND POLYMYXIN B SULFATE

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

FDA Submissions

ORIG

1

AP

2006-01-31

TE Codes

001

Prescription

AT

CDER Filings

XGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65108
            [companyName] => XGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOMYCIN AND POLYMYXIN B SULFATE","activeIngredients":"NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"EQ 40MG BASE\/ML;200,000 UNITS\/ML","dosageForm":"SOLUTION;IRRIGATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEOMYCIN AND POLYMYXIN B SULFATE","submission":"NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"EQ 40MG BASE\/ML;200,000 UNITS\/ML","submissionClassification":"SOLUTION;IRRIGATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)