NDA 050344

ALCON

FDA Drug Application

Application #050344

Application Sponsors

NDA 050344

ALCON

Marketing Status

• Discontinued: 002

Application Products

002

OINTMENT;OPHTHALMIC

EQ 3.5MG BASE/GM;10,000 UNITS/GM

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
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-02-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1989-03-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-06-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1981-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-03-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1992-08-24	STANDARD
LABELING; Labeling	SUPPL	8	AP	1983-11-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1983-11-23	STANDARD
LABELING; Labeling	SUPPL	10	AP	1984-08-08
LABELING; Labeling	SUPPL	13	AP	1993-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1996-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-11-29	STANDARD
LABELING; Labeling	SUPPL	16	AP	1997-09-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1999-02-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-09-28	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50344
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"STATROL","activeIngredients":"NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"EQ 3.5MG BASE\/GM;10,000 UNITS\/GM","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"STATROL","submission":"NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"EQ 3.5MG BASE\/GM;10,000 UNITS\/GM","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)