NDA 019407

JOHNSON AND JOHNSON

FDA Drug Application

Application #019407

Documents

• Letter: 2002-08-23

Application Sponsors

NDA 019407

JOHNSON AND JOHNSON

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.025%

1

VISINE L.R.

OXYMETAZOLINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1989-03-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1990-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-03-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-03-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-10-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-01-11	STANDARD
LABELING; Labeling	SUPPL	10	AP	2002-11-01	STANDARD

Submissions Property Types

SUPPL	2	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

CDER Filings

JOHNSON AND JOHNSON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19407
            [companyName] => JOHNSON AND JOHNSON
            [docInserts] => ["",""]
            [products] => [{"drugName":"VISINE L.R.","activeIngredients":"OXYMETAZOLINE HYDROCHLORIDE","strength":"0.025%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VISINE L.R.","submission":"OXYMETAZOLINE HYDROCHLORIDE","actionType":"0.025%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)