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FDA Drug Application 020413 by BRISTOL MYERS SQUIBB

Application Number020413
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
AP09/6/1996N       
AP02/4/1998SLR       
AP08/19/1998SCS       
AP07/1/1999SE1       
AP09/16/1998SLR       
AP09/27/2000SLR       
AP010/16/2001SLR5459006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20413s6lbl.pdf 4/25/2003
AP03/29/2002SE82044007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s16ltr.pdf 3/29/2002
AP03/29/2002SE82045007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20412s16lbl.pdf 3/29/2002
AP02/20/2002SLR2048008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s17s18ltr.pdf 2/20/2002
AP02/20/2002SLR2049009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20412s17s18ltr.pdf 2/20/2002
AP06/4/2004SLR9103014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20412slr023,20413slr014ltr.pdf 6/7/2004
AP06/4/2004SLR9122014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20412slr023,20413slr014_zerit_lbl.pdf 6/7/2004
AP012/20/2005SLR15770015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020413s015lbl.pdf 2/5/2007
AP04/20/2007SLR16315018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027, 020413s018_LTR.pdf 4/25/2007
AP04/20/2007SLR16767018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027,020413s018ltr.pdf 6/14/2007
AP16/6/2007SLR16315018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027, 020413s018_LTR.pdf 4/25/2007
AP16/6/2007SLR16767018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027,020413s018ltr.pdf 6/14/2007
AP26/13/2007SLR16315018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027, 020413s018_LTR.pdf 4/25/2007
AP26/13/2007SLR16767018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027,020413s018ltr.pdf 6/14/2007
AP36/21/2007SLR16315018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027, 020413s018_LTR.pdf 4/25/2007
AP36/21/2007SLR16767018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020412s027,020413s018ltr.pdf 6/14/2007
AP04/14/2008SLR19643020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s029, 020413s020ltr.pdf 4/16/2008
AP04/14/2008SLR19710020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s029,020413s020lbl.pdf 4/23/2008
AP04/14/2008SCS19645021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s030, 020413s021ltr.pdf 4/16/2008
AP04/14/2008SCS19711021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s030,020413s021lbl.pdf 4/23/2008
AP012/11/2008SLR21356023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020412s032, 020413s023ltr.pdf 12/18/2008
AP012/11/2008SLR21486023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020412s032,020413s023lbl.pdf 1/2/2009
AP02/13/2009SLR21860025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020412s033,020413s025ltr.pdf 2/18/2009
AP02/13/2009SLR21886025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020413s025,020412s033lbl.pdf 2/20/2009
AP07/8/2009SLR22930026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020412s034,020413s026lbl.pdf 7/9/2009
AP07/8/2009SLR22968026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020412s034,020413s026ltr.pdf 7/15/2009
AP012/10/2010SLR27366028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028MedG.pdf 12/23/2010
AP012/10/2010SLR27367028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020412s036,020413s028lbl.pdf 12/23/2010
AP012/10/2010SLR27392028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020412s036,020413s028ltr.pdf 12/28/2010
AP05/11/2011SLR28809029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020412s037,020413s029ltr.pdf 5/16/2011
AP011/18/2011SLR30728030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020412s038,020413s030ltr.pdf 11/22/2011
AP011/18/2011SLR30755030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020412s038,020413s030MG.pdf 11/22/2011
AP011/18/2011SLR30756030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020412s038,020413s030lbl.pdf 11/22/2011




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