ANDA 062339

ALCON

FDA Drug Application

Application #062339

Application Sponsors

ANDA 062339

ALCON

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 3.5MG BASE/ML;16,250 UNITS/ML

0

STATROL

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

FDA Submissions

	ORIG	1	AP	1984-11-30
LABELING; Labeling	SUPPL	5	AP	1993-04-14
LABELING; Labeling	SUPPL	6	AP	1993-08-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-08-04

Submissions Property Types

SUPPL

7

Null

0

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62339
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"STATROL","activeIngredients":"NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"EQ 3.5MG BASE\/ML;16,250 UNITS\/ML","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"STATROL","submission":"NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"EQ 3.5MG BASE\/ML;16,250 UNITS\/ML","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)