BAUSCH AND LOMB INC FDA Approval NDA 021664

NDA 021664

BAUSCH AND LOMB INC

FDA Drug Application

Application #021664

Documents

Letter2010-10-19
Letter2014-01-28
Letter2014-01-28
Label2005-03-29
Label2006-01-27
Label2014-01-28
Label2014-01-28
Letter2005-03-29
Letter2006-01-30
Letter2009-06-08
Label2009-06-04
Label2010-10-19
Review2007-06-29
Review2013-08-09

Application Sponsors

NDA 021664BAUSCH AND LOMB INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001SOLUTION/DROPS;OPHTHALMICEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1XIBROMBROMFENAC SODIUM
002SOLUTION/DROPS;OPHTHALMICEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1BROMDAYBROMFENAC SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2005-03-24STANDARD
LABELING; LabelingSUPPL10AP2009-06-02STANDARD
EFFICACY; EfficacySUPPL13AP2010-10-16STANDARD
LABELING; LabelingSUPPL14AP2014-01-27UNKNOWN
LABELING; LabelingSUPPL19AP2014-01-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2014-12-11STANDARD

Submissions Property Types

SUPPL13Null6
SUPPL14Null7
SUPPL19Null7
SUPPL20Null0

CDER Filings

BAUSCH AND LOMB INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21664
            [companyName] => BAUSCH AND LOMB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BROMDAY","activeIngredients":"BROMFENAC SODIUM","strength":"EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"XIBROM","activeIngredients":"BROMFENAC SODIUM","strength":"EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"01\/27\/2014","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021664s014s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2014","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021664s014s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2010","submission":"SUPPL-13","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021664s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2009","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021664s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2006","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021664s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021664lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BROMDAY","submission":"BROMFENAC SODIUM","actionType":"EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"XIBROM","submission":"BROMFENAC SODIUM","actionType":"EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-01-27
        )

)

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