ANDA 065187

AMRING PHARMS

FDA Drug Application

Application #065187

Application Sponsors

ANDA 065187

AMRING PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML

0

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

FDA Submissions

ORIG

1

AP

2005-10-28

TE Codes

001

Prescription

AT

CDER Filings

AMRING PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65187
            [companyName] => AMRING PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN","activeIngredients":"GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"0.025MG\/ML;EQ 1.75MG BASE\/ML;10,000 UNITS\/ML","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN","submission":"GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"0.025MG\/ML;EQ 1.75MG BASE\/ML;10,000 UNITS\/ML","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)