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FDA Drug Application 020154 by BRISTOL MYERS SQUIBB

Application Number020154
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority*
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/9/1991N26151000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201885.htm 8/9/2010
AP04/1/1992SCS       
AP02/4/1993SCP17526004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020154_S004_VIDEX.pdf 8/6/2007
AP09/25/1992SE2       
AP02/10/1994SLR       
AP08/21/1995SLR       
AP08/5/1994SE117527009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020154_S009_VIDEX.pdf 8/6/2007
AP04/13/1994SCS       
AP02/27/1996SCF       
AP08/21/1995SLR       
AP02/10/1994SLR       
AP08/21/1995SLR       
AP08/21/1995SLR       
AP06/26/1996SLR       
AP06/15/1995SLR       
AP07/14/1995SCS       
AP03/13/1996SCS       
AP07/17/1996SE117528020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020154_S020_VIDEX.pdf 8/6/2007
AP06/26/1996SLR       
AP07/31/1996SCM       
AP04/23/1998SLR       
AP01/5/1998SCS       
AP06/23/1998SCS       
AP011/25/1998SCS       
AP011/25/1998SCS       
AP07/1/1999SE110908028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s028_20-155s020_20156s021_Videx.cfm 1/6/2005
AP010/28/1999SE22585029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20154S29,30LTR.PDF 10/29/1999
AP010/28/1999SE22587029   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF 10/29/1999
AP010/28/1999SE29963029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s029s030_20-155s021_20-156s022_Videx.cfm 8/9/2004
AP010/28/1999SCF9964030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-154s029s030_20-155s021_20-156s022_Videx.cfm 8/9/2004
AP010/28/1999SCF2591030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20154S29,30LTR.PDF 10/29/1999
AP010/28/1999SCF2592030   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20154LBL.PDF 10/29/1999
AP07/3/2000SLR       
AP07/24/2000SLR11439032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm 4/19/2005
AP07/24/2000SE811440033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020154s032s033_020155s023s024_020156s024s025_Videx.cfm 4/19/2005
AP07/27/2001SLR       
AP09/10/2001SLR5397035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20154s35lbl.pdf 4/21/2003
AP011/16/2001SLR5398036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20154s36lbl.pdf 4/21/2003
AP04/1/2002SE82566037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154s037ltr.pdf 4/1/2002
AP04/1/2002SE82568037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf 4/1/2002
AP08/23/2002SCS       
AP09/25/2002SLR2520040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf 9/25/2002
AP09/25/2002SLR2521040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf 9/25/2002
AP09/25/2002SLR11462040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm 4/27/2005
AP09/25/2002SLR11463041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020154s040s041_020155s030s031_020156s031s032_Videx.cfm 4/27/2005
AP09/25/2002SLR2529041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20154slr040,041,20155slr030,031,20156slr031032ltr.pdf 9/25/2002
AP09/25/2002SLR2531041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf 9/25/2002
AP03/4/2003SLR4193042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf 3/6/2003
AP03/4/2003SLR4226042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20154slr042,20156slr033,20155slr032,21183slr007ltr.pdf 3/10/2003
AP01/21/2004SLR7582044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20154slr044,20155slr034,20156slr035,21183slr010ltr.pdf 1/22/2004
AP01/21/2004SLR7608044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf 1/22/2004
AP08/18/2006SLR14747049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf 8/21/2006
AP08/18/2006SLR14894049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s049, 020155s038, 020156s039, 021183s015LTR .pdf 9/18/2006
AP08/18/2006SLR18556049   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020154_S049_VIDEX.pdf 11/19/2007
AP011/29/2006SLR15414050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf 12/4/2006
AP011/29/2006SLR15580050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020154s050, 020155s039, 020156s040, 021183s016ltr.pdf 12/28/2006




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