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FDA Drug Application 009218 by BRISTOL MYERS SQUIBB

Application Number009218
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/8/1954N15834000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088578.pdf 2/20/2007
AP08/21/1975SLR       
AP09/27/1976SLR       
AP02/11/1977SCF       
AP012/5/1977SCS       
AP04/14/1978SCS       
AP07/6/1979SCP       
AP04/30/1980SCP       
AP02/1/1980SCS       
AP012/29/1980SCP       
AP07/6/1987SPD       
AP01/17/1985SLR       
AP02/25/1985SLR       
AP05/13/1985SLR       
AP07/8/1986SLR       
AP07/6/1987SLR       
AP07/1/1988SCF       
AP03/1/1990SCF       
AP03/1/1990SLR       
AP03/1/1990SLR       
AP04/25/1990SLR       
AP05/10/1991SCM       
AP04/11/1991SLR       
AP04/11/1991SLR       
AP012/15/1993SCM       
AP08/24/1993SCF       
AP08/20/1992SLR       
AP02/1/1993SLR       
AP06/8/1993SLR       
AP03/31/1994SE1       
AP08/6/1993SLR       
AP04/28/1995SE1       
AP02/7/1995SCF       
AP02/7/1995SCM       
AP03/8/1995SCS       
AP09/7/1995SLR       
AP011/18/1996SCF       
AP011/8/1996SCM       
AP09/5/1996SLR       
AP06/1/1998SLR2604086   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf 6/1/1998
AP011/23/1998SCP       
AP010/29/1997SCS       
AP04/16/1998SCP       
AP06/1/1998SLR2605090   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf 6/1/1998
AP06/1/1998SLR2606091   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf 6/1/1998
AP012/23/1998SCM       
AP03/31/1999SCM       
AP012/2/1999SCM       
AP07/9/1999SLR       
AP02/17/2000SLR2603097   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/09218S097_Coumadin.pdf 2/17/2000
AP05/3/2002SLR2602098   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09218s098ltr.pdf 5/3/2002
AP05/3/2002SLR2601099   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09218s099ltr.pdf 5/3/2002
AP09/2/2005SLR27028101   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/009218_s101_coumadin.pdf 9/2/2005
AP09/2/2005SLR12715101   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/009218s101lbl.pdf 9/7/2005
AP09/2/2005SLR12716101   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/009218s101ltr.pdf 9/7/2005
AP010/4/2006SLR15051102   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/009218s102LTR.pdf 10/5/2006
AP010/4/2006SLR15058102   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/009218s102lbl.pdf 10/5/2006
AP08/16/2007SLR17635105   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009218s105lblv2.pdf 8/16/2007
AP08/16/2007SLR17651105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009218s105ltr.pdf 8/17/2007
AP010/4/2011SLR30219107   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf 10/5/2011
AP010/4/2011SLR30221107   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009218s107ltr.pdf 10/5/2011
AP01/22/2010SLR24600108   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009218s108lbl.pdf 1/24/2010
AP01/22/2010SLR24654108   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009218s108ltr.pdf 1/28/2010
AP03/25/2013SCM       
AP012/2/2014SCM       
AP010/28/2015SLR44331115   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf 10/29/2015
AP010/28/2015SLR44336115   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009218Orig1s115ltr.pdf 10/30/2015
AP09/8/2016SLR47018116   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009218s116lbl.pdf 9/9/2016
AP09/8/2016SLR47023116   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/009218Orig1s116ltr.pdf 9/12/2016




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