NDA 022308

BAUSCH AND LOMB

FDA Drug Application

Application #022308

Documents

• Letter: 2009-06-02
• Letter: 2012-09-24
• Label: 2009-06-04
• Label: 2012-09-20
• Review: 2009-07-10
• Summary Review: 2009-07-10
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2018-04-05
• Letter: 2018-04-05

Application Sponsors

NDA 022308

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

EQ 0.6% BASE

1

BESIVANCE

BESIFLOXACIN HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2009-05-28	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2012-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2013-08-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2013-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2013-11-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2014-04-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2014-09-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2015-04-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2015-11-10	STANDARD
LABELING; Labeling	SUPPL	13	AP	2018-04-03	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	15
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
SUPPL	13	Null	15

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22308
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"BESIVANCE","activeIngredients":"BESIFLOXACIN HYDROCHLORIDE","strength":"EQ 0.6% BASE","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/03\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022308s013lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2012","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022308s003lbl.pdf\"}]","notes":""},{"actionDate":"05\/28\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022308lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BESIVANCE","submission":"BESIFLOXACIN HYDROCHLORIDE","actionType":"EQ 0.6% BASE","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-04-03
        )

)