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FDA Drug Application 011870 by SALIX PHARMS

Application Number011870
Application Type New Drug Application
Sponsor ApplicantSALIX PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/6/1961N       
AP03/27/1975SOA       
AP07/31/1978SLR       
AP010/31/1979SLR       
AP010/31/1979SLR       
AP07/13/1979SLR       
AP010/31/1979SLR       
AP01/13/1981SLR       
AP05/8/1987SPD       
AP03/6/1984SLR       
AP08/28/1984SLR       
AP011/4/1985SLR       
AP01/13/1986SLR       
AP03/2/1993SLR       
AP02/16/1994SLR       
AP05/23/1995SLR       
AP012/9/1998SLR       
AP02/25/2000SCM       
AP04/12/2001SCE       
AP09/26/2002SCS       
AP09/23/2004S10283036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s090,091,11870s036ltr.pdf 9/29/2004
AP08/10/2005SLR12578037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011145s093,011870s037ltr.pdf 8/11/2005
AP08/6/2007SLR17567039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011870s039ltr.pdf 8/7/2007
AP06/10/2009SLR22741040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011870s040lbl.pdf 6/10/2009
AP06/10/2009SLR22746040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011870s040ltr.pdf 6/16/2009




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