BRISTOL MYERS SQUIBB FDA Approval NDA 021798

NDA 021798

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #021798

Documents

Letter2007-03-06
Letter2007-03-31
Letter2007-07-27
Letter2008-07-31
Letter2008-06-06
Letter2009-07-22
Letter2009-02-27
Letter2012-10-15
Label2005-03-31
Label2007-03-31
Label2009-07-24
Label2009-03-17
Label2010-10-29
Label2012-10-15
Label2013-12-23
Label2014-03-25
Letter2005-03-31
Letter2011-01-04
Letter2012-10-15
Letter2013-12-20
Letter2014-03-21
Label2007-02-26
Label2007-07-27
Label2008-08-13
Label2010-12-28
Label2012-10-15
Review2005-12-06
Pediatric Written Request2006-11-28
Pediatric Amendment 12007-04-23
Pediatric Amendment 22010-06-28
Pediatric Amendment 32013-05-31
Letter2018-06-27
Label2018-07-06
Letter2018-12-21
Label2018-12-21
Letter2019-11-12
Label2019-11-19
Pediatric Written Request1900-01-01
Pediatric Amendment 11900-01-01
Pediatric Amendment 21900-01-01
Pediatric Amendment 31900-01-01

Application Sponsors

NDA 021798BRISTOL MYERS SQUIBB

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL0.05MG/ML1BARACLUDEENTECAVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2005-03-29PRIORITY
EFFICACY; EfficacySUPPL2AP2007-03-27UNKNOWN
LABELING; LabelingSUPPL3AP2007-07-24STANDARD
EFFICACY; EfficacySUPPL6AP2008-07-25STANDARD
LABELING; LabelingSUPPL7AP2008-06-03STANDARD
EFFICACY; EfficacySUPPL8AP2009-07-16UNKNOWN
LABELING; LabelingSUPPL10AP2009-02-25STANDARD
EFFICACY; EfficacySUPPL11AP2010-10-15STANDARD
LABELING; LabelingSUPPL12AP2010-12-28STANDARD
EFFICACY; EfficacySUPPL14AP2012-10-12STANDARD
EFFICACY; EfficacySUPPL16AP2012-10-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2013-06-18PRIORITY
LABELING; LabelingSUPPL18AP2013-12-19STANDARD
EFFICACY; EfficacySUPPL19AP2014-03-20PRIORITY
LABELING; LabelingSUPPL21AP2018-06-22STANDARD
LABELING; LabelingSUPPL23AP2018-12-20STANDARD
LABELING; LabelingSUPPL24AP2019-11-06STANDARD

Submissions Property Types

SUPPL6Null6
SUPPL8Null6
SUPPL11Null6
SUPPL12Null6
SUPPL14Null7
SUPPL16Null7
SUPPL17Null0
SUPPL18Null15
SUPPL19Null15
SUPPL21Null31
SUPPL23Null15
SUPPL24Null15

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21798
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"BARACLUDE","activeIngredients":"ENTECAVIR","strength":"0.05MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/06\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021797s023,021798s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021797s021,021798s023lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021797s021,021798s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021798s021lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021798s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2014","submission":"SUPPL-19","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021797s018,021798s019lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2013","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021797s017,021798s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2013","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021797s017,021798s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2013","submission":"SUPPL-18","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021797s017,021798s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2012","submission":"SUPPL-16","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021797s013s014,021798s014s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2012","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021797s013s014,021798s014s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2010","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021798s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2010","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021797s010,021798s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2009","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"02\/25\/2009","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021797s009,021798s010lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2008","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021797s005,021798s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2007","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021797s003,021798s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2007","submission":"SUPPL-2","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021797s002,021798s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2007","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021797s001,021798s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021797,021798lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BARACLUDE","submission":"ENTECAVIR","actionType":"0.05MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-11-06
        )

)
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