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FDA Drug Application 020156 by BRISTOL MYERS SQUIBB

Application Number020156
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
AP010/9/1991N26153000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201885.htm 8/9/2010
AP09/25/1992SE2       
AP02/10/1994SLR       
AP08/21/1995SLR       
AP08/5/1994SE117531007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020156_S007_VIDEX.pdf 8/6/2007
AP08/21/1995SLR       
AP02/10/1994SLR       
AP08/21/1995SLR       
AP08/21/1995SLR       
AP06/26/1996SLR       
AP06/15/1995SLR       
AP07/14/1995SCS       
AP03/13/1996SCS       
AP07/17/1996SE117532016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020156_S016_VIDEX.pdf 8/6/2007
AP06/26/1996SLR       
AP04/23/1998SLR       
AP06/23/1998SCS       
AP03/5/1998SCP       
AP07/1/1999SE110910021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s028_20-155s020_20156s021_Videx.cfm 1/6/2005
AP010/28/1999SE22598022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20154S29,30LTR.PDF 10/29/1999
AP010/28/1999SE22599022   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF 10/21/1999
AP010/28/1999SE29966022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s029s030_20-155s021_20-156s022_Videx.cfm 8/9/2004
AP07/3/2000SLR       
AP07/24/2000SLR11443024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm 4/19/2005
AP07/24/2000SE811444025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm 4/19/2005
AP07/27/2001SLR       
AP09/10/2001SLR5401027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20156s27lbl.pdf 4/21/2003
AP011/16/2001SLR5402028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20156s28lbl.pdf 4/21/2003
AP04/1/2002SE82573029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154s037ltr.pdf 4/1/2002
AP04/1/2002SE82574029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf 4/1/2002
AP09/25/2002SLR11466031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm 4/27/2005
AP09/25/2002SLR2537031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf 9/25/2002
AP09/25/2002SLR2539031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf 9/25/2002
AP09/25/2002SLR2541032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf 9/25/2002
AP09/25/2002SLR2543032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf 9/25/2002
AP09/25/2002SLR11467032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm 4/27/2005
AP03/4/2003SLR4214033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf 3/7/2003
AP03/4/2003SLR4227033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20154slr042,20156slr033,20155slr032,21183slr007ltr.pdf 3/10/2003
AP01/21/2004SLR7584035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20154slr044,20155slr034,20156slr035,21183slr010ltr.pdf 1/22/2004
AP01/21/2004SLR7610035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf 1/22/2004
AP08/18/2006SLR18554039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020156_S039_VIDEX.pdf 11/19/2007
AP08/18/2006SLR14745039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf 8/21/2006
AP08/18/2006SLR14892039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s049, 020155s038, 020156s039, 021183s015LTR .pdf 9/18/2006
AP011/29/2006SLR15412040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf 12/4/2006
AP011/29/2006SLR15578040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s050, 020155s039, 020156s040, 021183s016ltr.pdf 12/28/2006
AP06/10/2009SLR22760044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020156s044ltr.pdf 6/17/2009
AP06/10/2009SLR22781044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020156s044lbl.pdf 6/22/2009
AP01/25/2010SLR24672046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020156s046lbl.pdf 1/29/2010
AP01/25/2010SLR24673046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020156s046MedGuide.pdf 1/29/2010
AP01/25/2010SLR24696046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020156s046,021183s023ltr.pdf 2/1/2010
AP05/10/2011SLR28786047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020156s047,021183s024ltr.pdf 5/12/2011
AP011/18/2011SLR30726048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020156s048ltr.pdf 11/22/2011
AP011/18/2011SLR30759048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020156s048MG.pdf 11/22/2011
AP011/18/2011SLR30760048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020156s048lbl.pdf 11/22/2011
AP08/8/2014SLR40200051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020156Orig1s051ltr.pdf 8/12/2014
AP08/8/2014SLR40207051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020156s051lbl.pdf 8/12/2014




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