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FDA Drug Application 021183 by BRISTOL MYERS SQUIBB

Application Number021183
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/31/2000N1403000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21183lbl1.pdf 10/31/2000
AP010/31/2000N7915000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-183_Videx.cfm 3/11/2004
AP010/31/2000N9620000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-183_Videx_Approv.pdf 6/30/2004
AP010/31/2000N26154000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201885.htm 8/9/2010
AP01/28/2002SLR2516001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183s1ltr.pdf 1/28/2002
AP01/28/2002SLR17138001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021183_S001_VIDEX_AP.pdf 7/9/2007
AP01/29/2002SE811361002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-183s002_Videx.cfm 4/8/2005
AP01/29/2002SE82514002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183s2ltr.pdf 1/29/2002
AP04/1/2002SE82577003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154s037ltr.pdf 4/1/2002
AP04/1/2002SE82579003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf 4/1/2002
AP08/5/2002SLR2512004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183slr004ltr.pdf 8/5/2002
AP08/5/2002SLR2513004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s4lbl.pdf 8/5/2002
AP010/16/2002SLR2503005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183slr005,006ltr.pdf 9/26/2002
AP010/16/2002SLR2508005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s5s6lbl.pdf 9/26/2002
AP010/16/2002SLR2510006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21183slr005,006ltr.pdf 9/26/2002
AP010/16/2002SLR2511006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21183s5s6lbl.pdf 9/26/2002
AP03/4/2003SLR4216007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf 3/7/2003
AP03/4/2003SLR4229007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20154slr042,20156slr033,20155slr032,21183slr007ltr.pdf 3/10/2003
AP01/21/2004SLR7585010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20154slr044,20155slr034,20156slr035,21183slr010ltr.pdf 1/22/2004
AP01/21/2004SLR7611010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf 1/22/2004
AP08/18/2006SLR14744015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf 8/21/2006
AP08/18/2006SLR14891015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s049, 020155s038, 020156s039, 021183s015LTR .pdf 9/18/2006
AP011/29/2006SLR15411016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf 12/4/2006
AP011/29/2006SLR15577016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s050, 020155s039, 020156s040, 021183s016ltr.pdf 12/28/2006
AP09/29/2008SE520918020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021183s020ltr.pdf 10/2/2008
AP09/29/2008SE520944020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021183s020lbl.pdf 10/3/2008
AP06/10/2009SLR22759022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021183s022ltr.pdf 6/16/2009
AP06/10/2009SLR22780022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021183s022lbl.pdf 6/22/2009
AP01/25/2010SLR24674023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021183s023lbl.pdf 1/29/2010
AP01/25/2010SLR24675023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021183s023MedGuide.pdf 1/29/2010
AP01/25/2010SLR24697023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020156s046,021183s023ltr.pdf 2/1/2010
AP05/10/2011SLR28787024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020156s047,021183s024ltr.pdf 5/12/2011
AP011/18/2011SLR30738025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021183s025ltr.pdf 11/22/2011
AP011/18/2011SLR30757025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021183s025MG.pdf 11/22/2011
AP011/18/2011SLR30758025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021183s025lbl.pdf 11/22/2011




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