NDA 020065

BAUSCH AND LOMB

FDA Drug Application

Application #020065

Documents

• Letter: 2005-04-28
• Letter: 2007-08-02
• Label: 2007-08-02
• Letter: 2022-09-26
• Label: 2022-10-05

Application Sponsors

NDA 020065

BAUSCH AND LOMB

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.02675%;0.315%

1

OPCON-A

NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1994-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-05-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2005-04-20	STANDARD
LABELING; Labeling	SUPPL	11	AP	1996-05-09	STANDARD
LABELING; Labeling	SUPPL	13	AP	1996-07-23	STANDARD
LABELING; Labeling	SUPPL	14	AP	1996-07-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-12-18	STANDARD
LABELING; Labeling	SUPPL	17	AP	2007-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2015-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2015-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2016-03-14	STANDARD
LABELING; Labeling	SUPPL	33	AP	2022-09-23	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	15	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	33	Null	31

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20065
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"OPCON-A","activeIngredients":"NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE","strength":"0.02675%;0.315%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/31\/2007","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020065s017lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OPCON-A","submission":"NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE","actionType":"0.02675%;0.315%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2007-07-31
        )

)