NDA 019387

ALCON

FDA Drug Application

Application #019387

Application Sponsors

NDA 019387

ALCON

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

1%

0

PROFENAL

SUPROFEN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1988-12-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	1992-08-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-08-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1993-01-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-11-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-01-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-01-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-02-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-08-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-02-18	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19387
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROFENAL","activeIngredients":"SUPROFEN","strength":"1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROFENAL","submission":"SUPROFEN","actionType":"1%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)