ANDA 065216

AMRING PHARMS

FDA Drug Application

Application #065216

Application Sponsors

ANDA 065216

AMRING PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OTIC

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

0

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

FDA Submissions

ORIG

1

AP

2005-10-31

CDER Filings

AMRING PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65216
            [companyName] => AMRING PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE","activeIngredients":"HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"1%;EQ 3.5MG BASE\/ML;10,000 UNITS\/ML","dosageForm":"SOLUTION\/DROPS;OTIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE","submission":"HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"1%;EQ 3.5MG BASE\/ML;10,000 UNITS\/ML","submissionClassification":"SOLUTION\/DROPS;OTIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)