NDA 020485

JOHNSON AND JOHNSON

FDA Drug Application

Application #020485

Documents

• Letter: 2004-10-22
• Label: 2002-06-14
• Label: 2014-01-14
• Letter: 2002-06-14
• Letter: 2003-09-25
• Letter: 2012-12-21
• Label: 2003-09-25
• Label: 2016-08-26
• Letter: 2018-10-23
• Label: 2018-10-26

Application Sponsors

NDA 020485

JOHNSON AND JOHNSON

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.025%;0.3%

1

VISINE

NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1996-01-31	STANDARD
LABELING; Labeling	SUPPL	2	AP	1996-09-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	1998-11-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-03-11	STANDARD
LABELING; Labeling	SUPPL	5	AP	2002-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2003-09-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	2004-10-15	STANDARD
LABELING; Labeling	SUPPL	9	AP	2012-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2016-03-10	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2017-01-06	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2018-10-17	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	7
SUPPL	10	Null	0
SUPPL	11	Null	6
SUPPL	13	Null	15

CDER Filings

JOHNSON AND JOHNSON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20485
            [companyName] => JOHNSON AND JOHNSON
            [docInserts] => ["",""]
            [products] => [{"drugName":"VISINE","activeIngredients":"NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE","strength":"0.025%;0.3%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/17\/2018","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020485Orig1s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020485Orig1s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020485Orig1s009Lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2003","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20485scm006_visine_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"06\/14\/2002","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20485s005lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VISINE","submission":"NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE","actionType":"0.025%;0.3%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-10-17
        )

)