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FDA Drug Application 020155 by BRISTOL MYERS SQUIBB

Application Number020155
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
AP010/9/1991N26152000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201885.htm 8/9/2010
AP09/25/1992SE2       
AP02/10/1994SLR       
AP08/21/1995SLR       
AP08/5/1994SE117529007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020155_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       
AP07/17/1996SE117530016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020155_S007_VIDEX.pdf 8/6/2007
AP06/26/1996SLR       
AP04/23/1998SLR       
AP06/23/1998SCS       
AP07/1/1999SE110909020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s028_20-155s020_20156s021_Videx.cfm 1/6/2005
AP010/28/1999SE22593021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20154S29,30LTR.PDF 10/29/1999
AP010/28/1999SE22595021   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF 10/29/1999
AP010/28/1999SE29965021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s029s030_20-155s021_20-156s022_Videx.cfm 8/9/2004
AP07/3/2000SLR       
AP07/24/2000SLR11441023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm 4/19/2005
AP07/24/2000SE811442024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm 4/19/2005
AP07/27/2001SLR       
AP09/10/2001SLR5399026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20155s26lbl.pdf 4/21/2003
AP011/16/2001SLR5400027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20155s27lbl.pdf 4/21/2003
AP04/1/2002SE82570028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154s037ltr.pdf 4/1/2002
AP04/1/2002SE82571028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf 4/1/2002
AP09/25/2002SLR2532030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf 9/25/2002
AP09/25/2002SLR2534030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf 9/25/2002
AP09/25/2002SLR11464030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm 4/27/2005
AP09/25/2002SLR9621031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf 6/30/2004
AP09/25/2002SLR9622031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf 6/30/2004
AP09/25/2002SLR11465031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm 4/27/2005
AP03/4/2003SLR4215032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf 3/7/2003
AP03/4/2003SLR4228032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20154slr042,20156slr033,20155slr032,21183slr007ltr.pdf 3/10/2003
AP01/21/2004SLR7583034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20154slr044,20155slr034,20156slr035,21183slr010ltr.pdf 1/22/2004
AP01/21/2004SLR7609034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf 1/22/2004
AP08/18/2006SLR14746038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf 8/21/2006
AP08/18/2006SLR14893038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s049, 020155s038, 020156s039, 021183s015LTR .pdf 9/18/2006
AP08/18/2006SLR18555038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020155_S038_VIDEX.pdf 11/19/2007
AP011/29/2006SLR15413039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf 12/4/2006
AP011/29/2006SLR15579039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s050, 020155s039, 020156s040, 021183s016ltr.pdf 12/28/2006




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