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FDA Drug Application 020740 by BAYER PHARMS

Application Number020740
Application Type New Drug Application
Sponsor ApplicantBAYER PHARMS
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
AP06/26/1997N24879000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020740_baycol_toc.cfm 3/2/2010
AP08/20/1998SCS       
AP05/24/1999SE23846002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20740s02ltr.pdf 5/24/1999
AP05/24/1999SE23847002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-740S002_Baycol.cfm 11/29/2001
AP01/4/1999SLR3848003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-740S003_Baycol.pdf 11/29/2001
AP07/13/1999SCS       
AP08/23/1999SCE       
AP03/30/2001SLR1392006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20740S6ltr.pdf 3/30/2001
AP03/30/2001SLR1393006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S6lbl.pdf 3/30/2001
AP03/30/2001SLR3849006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S006_Baycol.pdf 12/3/2001
AP012/10/1999SCS17922007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020740s007.pdf 9/24/2007
AP07/21/2000SE23850008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20740S8,13LTR.PDF 7/23/2000
AP07/21/2000SE23851008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol.cfm 11/29/2001
AP07/21/2000SE24534008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf 7/21/2000
AP012/22/1999SCS17921010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020740_S010_BAYCOL.pdf 9/24/2007
AP07/3/2000SCM17920012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020740_S012_BAYCOL.pdf 9/24/2007
AP07/21/2000SE13852013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20740S8,13LTR.PDF 7/23/2000
AP07/21/2000SE13853013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol.cfm 11/29/2001
AP07/21/2000SE14535013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf 7/21/2000
AP011/6/2000SLR3854014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S014_Baycol.pdf 12/3/2001
AP01/23/2001SCE19160016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020740_S016_BAYCOL_TABLETS.pdf 2/19/2008
AP02/27/2001SCM       
AP05/10/2001SCS3855018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S018_Baycol.pdf 12/3/2001
AP05/10/2001SCS5415018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S18lbl.pdf 4/22/2003
AP05/21/2001SLR4434019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S019_Baycol.pdf 12/3/2001
AP05/21/2001SLR5430019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S19lbl.pdf 4/23/2002




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