BAUSCH AND LOMB FDA Approval NDA 021737

NDA 021737

BAUSCH AND LOMB

FDA Drug Application

Application #021737

Documents

Letter2005-04-12
Letter2010-12-03
Letter2011-06-06
Label2005-04-12
Label2011-06-07
Letter2007-11-08
Letter2008-08-07
Label2007-11-07
Review2007-01-22

Application Sponsors

NDA 021737BAUSCH AND LOMB

Marketing Status

Prescription001

Application Products

001IMPLANT;INTRAVITREAL0.59MG1RETISERTFLUOCINOLONE ACETONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2004-11-04PRIORITY
LABELING; LabelingSUPPL7AP2007-10-30STANDARD
EFFICACY; EfficacySUPPL10AP2008-08-05UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2010-11-30PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2011-06-02N/A
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2014-06-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2015-03-30PRIORITY

Submissions Property Types

ORIG1Orphan5
SUPPL10Null6
SUPPL18Null14
SUPPL19Null6
SUPPL21Null14
SUPPL22Null14

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21737
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"RETISERT","activeIngredients":"FLUOCINOLONE ACETONIDE","strength":"0.59MG","dosageForm":"IMPLANT;INTRAVITREAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/02\/2011","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021737s019.pdf\"}]","notes":""},{"actionDate":"10\/30\/2007","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021737s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021737lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RETISERT","submission":"FLUOCINOLONE ACETONIDE","actionType":"0.59MG","submissionClassification":"IMPLANT;INTRAVITREAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2011-06-02
        )

)

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