NDA 022288

BAUSCH AND LOMB INC

FDA Drug Application

Application #022288

Documents

• Letter: 2009-09-16
• Letter: 2012-06-29
• Label: 2009-09-18
• Label: 2012-06-29
• Review: 2009-10-21
• Summary Review: 2009-10-21
• Label: 2018-02-09
• Letter: 2018-02-09
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01

Application Sponsors

NDA 022288

BAUSCH AND LOMB INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

1.5%

1

BEPREVE

BEPOTASTINE BESILATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2009-09-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2012-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2016-02-05	STANDARD
LABELING; Labeling	SUPPL	8	AP	2018-02-09	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	0
SUPPL	8	Null	6

TE Codes

001

Prescription

AT

CDER Filings

BAUSCH AND LOMB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22288
            [companyName] => BAUSCH AND LOMB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BEPREVE","activeIngredients":"BEPOTASTINE BESILATE","strength":"1.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/09\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022288s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2012","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022288s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/08\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022288lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BEPREVE","submission":"BEPOTASTINE BESILATE","actionType":"1.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-02-09
        )

)