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FDA Drug Application 020412 by BRISTOL MYERS SQUIBB

Application Number020412
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
AP06/24/1994N       
AP08/2/1994SCS       
AP012/21/1995SE1       
AP02/9/1996SCS       
AP09/6/1996SE5       
AP02/4/1998SLR       
AP09/26/1997SCM       
AP02/3/1998SCS       
AP01/16/1998SCM       
AP08/19/1998SCS       
AP07/1/1999SE1       
AP09/16/1998SLR       
AP06/10/1999SCM       
AP09/27/2000SLR       
AP04/17/2001SCS       
AP010/16/2001SLR5412015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20412s15lbl.pdf 4/22/2003
AP03/29/2002SE82042016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s16ltr.pdf 3/29/2002
AP03/29/2002SE82043016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20412s16lbl.pdf 3/29/2002
AP02/20/2002SLR2046017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s17s18ltr.pdf 2/20/2002
AP02/20/2002SLR2047018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s17s18ltr.pdf 2/20/2002
AP06/4/2004SLR9101023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20412slr023,20413slr014ltr.pdf 6/7/2004
AP06/4/2004SLR9120023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20412slr023,20413slr014_zerit_lbl.pdf 6/7/2004
AP012/20/2005SLR15769024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020412s024lbl.pdf 2/5/2007
AP04/20/2007SLR16314027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027, 020413s018_LTR.pdf 4/25/2007
AP04/20/2007SLR16768027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027,020413s018ltr.pdf 6/14/2007
AP16/6/2007SLR16314027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027, 020413s018_LTR.pdf 4/25/2007
AP16/6/2007SLR16768027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027,020413s018ltr.pdf 6/14/2007
AP26/13/2007SLR16314027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027, 020413s018_LTR.pdf 4/25/2007
AP26/13/2007SLR16768027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027,020413s018ltr.pdf 6/14/2007
AP36/21/2007SLR16314027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027, 020413s018_LTR.pdf 4/25/2007
AP36/21/2007SLR16768027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027,020413s018ltr.pdf 6/14/2007
AP04/14/2008SLR19642029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s029, 020413s020ltr.pdf 4/16/2008
AP04/14/2008SLR19709029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s029,020413s020lbl.pdf 4/23/2008
AP04/14/2008SLR19644030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s030, 020413s021ltr.pdf 4/16/2008
AP04/14/2008SLR19712030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s030,020413s021lbl.pdf 4/23/2008
AP012/11/2008SLR21355032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s032, 020413s023ltr.pdf 12/18/2008
AP012/11/2008SLR21485032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s032,020413s023lbl.pdf 1/2/2009
AP02/13/2009SLR21859033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020412s033,020413s025ltr.pdf 2/18/2009
AP02/13/2009SLR21887033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020413s025,020412s033lbl.pdf 2/20/2009
AP07/8/2009SLR22929034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020412s034,020413s026lbl.pdf 7/9/2009
AP07/8/2009SLR22967034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020412s034,020413s026ltr.pdf 7/15/2009
AP012/10/2010SLR27365036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028MedG.pdf 12/23/2010
AP012/10/2010SLR27368036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028lbl.pdf 12/23/2010
AP012/10/2010SLR27391036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020412s036,020413s028ltr.pdf 12/28/2010
AP05/11/2011SLR28808037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020412s037,020413s029ltr.pdf 5/16/2011
AP011/18/2011SLR30727038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020412s038,020413s030ltr.pdf 11/22/2011
AP011/18/2011SLR30753038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020412s038,020413s030MG.pdf 11/22/2011
AP011/18/2011SLR30754038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020412s038,020413s030lbl.pdf 11/22/2011
AP07/14/2015SCM       




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