BRISTOL MYERS SQUIBB FDA Approval NDA 020155

NDA 020155

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #020155

Documents

Letter2002-04-01
Letter2004-06-30
Letter2004-01-22
Letter2006-09-18
Label2003-04-21
Label2002-04-01
Label2002-09-25
Label2003-03-07
Label2006-08-21
Review2007-08-06
Review2005-01-06
Review2005-04-19
Letter1999-10-29
Letter2002-09-25
Letter2003-03-10
Letter2006-12-28
Label1999-10-29
Label2003-04-21
Label2004-06-30
Label2004-01-22
Label2006-12-04
Review2007-08-06
Review2004-08-09
Review2005-04-19
Review2005-04-27
Review2005-04-27
Review2007-11-19
Other Important Information from FDA2010-08-09

Application Sponsors

NDA 020155BRISTOL MYERS SQUIBB

Marketing Status

Discontinued003
Discontinued004
Discontinued005
Discontinued006

Application Products

003FOR SOLUTION;ORAL100MG/PACKET0VIDEXDIDANOSINE
004FOR SOLUTION;ORAL167MG/PACKET0VIDEXDIDANOSINE
005FOR SOLUTION;ORAL250MG/PACKET0VIDEXDIDANOSINE
006FOR SOLUTION;ORAL375MG/PACKET0VIDEXDIDANOSINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1991-10-09PRIORITY
EFFICACY; EfficacySUPPL4AP1992-09-25
LABELING; LabelingSUPPL5AP1994-02-10STANDARD
LABELING; LabelingSUPPL6AP1995-08-21STANDARD
EFFICACY; EfficacySUPPL7AP1994-08-05PRIORITY
LABELING; LabelingSUPPL8AP1995-08-21STANDARD
LABELING; LabelingSUPPL9AP1994-02-10STANDARD
LABELING; LabelingSUPPL10AP1995-08-21STANDARD
LABELING; LabelingSUPPL11AP1995-08-21STANDARD
LABELING; LabelingSUPPL12AP1996-06-26STANDARD
LABELING; LabelingSUPPL13AP1995-06-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1995-07-14
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1996-03-13
EFFICACY; EfficacySUPPL16AP1996-07-17STANDARD
LABELING; LabelingSUPPL17AP1996-06-26STANDARD
LABELING; LabelingSUPPL18AP1998-04-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1998-06-23
EFFICACY; EfficacySUPPL20AP1999-07-01STANDARD
EFFICACY; EfficacySUPPL21AP1999-10-28PRIORITY
LABELING; LabelingSUPPL22AP2000-07-03STANDARD
LABELING; LabelingSUPPL23AP2000-07-24STANDARD
EFFICACY; EfficacySUPPL24AP2000-07-24STANDARD
LABELING; LabelingSUPPL25AP2001-07-27STANDARD
LABELING; LabelingSUPPL26AP2001-09-10STANDARD
LABELING; LabelingSUPPL27AP2001-11-16STANDARD
EFFICACY; EfficacySUPPL28AP2002-04-01UNKNOWN
LABELING; LabelingSUPPL30AP2002-09-25STANDARD
LABELING; LabelingSUPPL31AP2002-09-25STANDARD
LABELING; LabelingSUPPL32AP2003-03-04STANDARD
LABELING; LabelingSUPPL34AP2004-01-21STANDARD
LABELING; LabelingSUPPL38AP2006-08-18STANDARD
LABELING; LabelingSUPPL39AP2006-11-29STANDARD

Submissions Property Types

ORIG1Null11
SUPPL14Null0
SUPPL15Null0
SUPPL19Null0
SUPPL28Null26

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20155
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIDEX","activeIngredients":"DIDANOSINE","strength":"100MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VIDEX","activeIngredients":"DIDANOSINE","strength":"167MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VIDEX","activeIngredients":"DIDANOSINE","strength":"250MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VIDEX","activeIngredients":"DIDANOSINE","strength":"375MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/29\/2006","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020154s50,20155s39,20156s40,21183s16lbl.pdf\"}]","notes":""},{"actionDate":"08\/18\/2006","submission":"SUPPL-38","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020154s49,20155s38,20156s39,21183s15lbl.pdf\"}]","notes":""},{"actionDate":"01\/21\/2004","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2003","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2002","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20154s40,s41lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2002","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20154s40,s41lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2002","submission":"SUPPL-28","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20154s37lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2001","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20155s27lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2001","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20155s26lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/1999","submission":"SUPPL-21","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20154LBL.PDF\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VIDEX","submission":"DIDANOSINE","actionType":"100MG\/PACKET","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VIDEX","submission":"DIDANOSINE","actionType":"167MG\/PACKET","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VIDEX","submission":"DIDANOSINE","actionType":"250MG\/PACKET","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VIDEX","submission":"DIDANOSINE","actionType":"375MG\/PACKET","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2006-11-29
        )

)
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