NDA 050456

ALCON

FDA Drug Application

Application #050456

Documents

• Review: 2003-09-11

Application Sponsors

NDA 050456

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

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1974-03-12	STANDARD
LABELING; Labeling	SUPPL	3	AP	1993-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1976-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1976-09-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1977-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1978-02-09	STANDARD
LABELING; Labeling	SUPPL	9	AP	1978-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1978-09-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1981-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1983-07-28	STANDARD
LABELING; Labeling	SUPPL	14	AP	1984-08-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1987-05-15	STANDARD
LABELING; Labeling	SUPPL	16	AP	1987-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1989-03-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1995-11-01	STANDARD
LABELING; Labeling	SUPPL	20	AP	1997-09-09	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50456
            [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
        )

)