NDA 014169

ALCON

FDA Drug Application

Application #014169

Application Sponsors

NDA 014169

ALCON

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.1%

1

DENDRID

IDOXURIDINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1963-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1977-05-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1977-08-22	STANDARD
LABELING; Labeling	SUPPL	10	AP	1979-01-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1985-09-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-07-26	STANDARD

Submissions Property Types

SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 14169
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"DENDRID","activeIngredients":"IDOXURIDINE","strength":"0.1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DENDRID","submission":"IDOXURIDINE","actionType":"0.1%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)