BRISTOL MYERS SQUIBB FDA Approval NDA 020154

NDA 020154

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #020154

Documents

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

Application Sponsors

NDA 020154BRISTOL MYERS SQUIBB

Marketing Status

Discontinued002
Discontinued003
Discontinued004
Discontinued005
Discontinued006

Application Products

002TABLET, CHEWABLE;ORAL25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1VIDEXDIDANOSINE
003TABLET, CHEWABLE;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1VIDEXDIDANOSINE
004TABLET, CHEWABLE;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1VIDEXDIDANOSINE
005TABLET, CHEWABLE;ORAL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1VIDEXDIDANOSINE
006TABLET, CHEWABLE;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1VIDEXDIDANOSINE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1991-10-09PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1993-02-04
EFFICACY; EfficacySUPPL6AP1992-09-25
LABELING; LabelingSUPPL7AP1994-02-10STANDARD
LABELING; LabelingSUPPL8AP1995-08-21STANDARD
EFFICACY; EfficacySUPPL9AP1994-08-05PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1994-04-13
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1996-02-27
LABELING; LabelingSUPPL12AP1995-08-21STANDARD
LABELING; LabelingSUPPL13AP1994-02-10STANDARD
LABELING; LabelingSUPPL14AP1995-08-21STANDARD
LABELING; LabelingSUPPL15AP1995-08-21STANDARD
LABELING; LabelingSUPPL16AP1996-06-26STANDARD
LABELING; LabelingSUPPL17AP1995-06-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1995-07-14
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1996-03-13
EFFICACY; EfficacySUPPL20AP1996-07-17STANDARD
LABELING; LabelingSUPPL21AP1996-06-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1996-07-31
LABELING; LabelingSUPPL23AP1998-04-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL24AP1998-01-05
MANUF (CMC); Manufacturing (CMC)SUPPL25AP1998-06-23
MANUF (CMC); Manufacturing (CMC)SUPPL26AP1998-11-25
MANUF (CMC); Manufacturing (CMC)SUPPL27AP1998-11-25
EFFICACY; EfficacySUPPL28AP1999-07-01STANDARD
EFFICACY; EfficacySUPPL29AP1999-10-28PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL30AP1999-10-28
LABELING; LabelingSUPPL31AP2000-07-03STANDARD
LABELING; LabelingSUPPL32AP2000-07-24STANDARD
EFFICACY; EfficacySUPPL33AP2000-07-24STANDARD
LABELING; LabelingSUPPL34AP2001-07-27STANDARD
LABELING; LabelingSUPPL35AP2001-09-10STANDARD
LABELING; LabelingSUPPL36AP2001-11-16STANDARD
EFFICACY; EfficacySUPPL37AP2002-04-01UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2002-08-23
LABELING; LabelingSUPPL40AP2002-09-25STANDARD
LABELING; LabelingSUPPL41AP2002-09-25STANDARD
LABELING; LabelingSUPPL42AP2003-03-04STANDARD
LABELING; LabelingSUPPL44AP2004-01-21STANDARD
LABELING; LabelingSUPPL50AP2006-11-29STANDARD

Submissions Property Types

ORIG1Null39
SUPPL4Null0
SUPPL10Null0
SUPPL11Null0
SUPPL18Null0
SUPPL19Null0
SUPPL22Null0
SUPPL24Null0
SUPPL25Null0
SUPPL26Null0
SUPPL27Null0
SUPPL30Null0
SUPPL37Null6
SUPPL39Null0

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20154
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIDEX","activeIngredients":"DIDANOSINE","strength":"25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"VIDEX","activeIngredients":"DIDANOSINE","strength":"50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"VIDEX","activeIngredients":"DIDANOSINE","strength":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"VIDEX","activeIngredients":"DIDANOSINE","strength":"150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"VIDEX","activeIngredients":"DIDANOSINE","strength":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/29\/2006","submission":"SUPPL-50","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020154s50,20155s39,20156s40,21183s16lbl.pdf\"}]","notes":""},{"actionDate":"01\/21\/2004","submission":"SUPPL-44","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-42","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-41","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-40","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-37","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-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20154s36lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2001","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20154s35lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/1999","submission":"SUPPL-30","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20154LBL.PDF\"}]","notes":""},{"actionDate":"10\/28\/1999","submission":"SUPPL-29","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":"25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"VIDEX","submission":"DIDANOSINE","actionType":"50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"VIDEX","submission":"DIDANOSINE","actionType":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"VIDEX","submission":"DIDANOSINE","actionType":"150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"VIDEX","submission":"DIDANOSINE","actionType":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2006-11-29
        )

)
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