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FDA Drug Application 019527 by SALIX PHARMS

Application Number019527
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
AP02/2/1987N       
AP011/23/1988SLR       
AP09/29/1995SCM       
AP010/28/1988SLR       
AP011/30/1990SLR       
AP011/30/1990SLR       
AP012/10/1991SLR       
AP08/22/1997SLR       
AP011/30/1990SLR       
AP03/29/1996SLR       
AP03/29/1996SLR       
AP03/29/1996SLR       
AP02/1/1996SCS       
AP08/12/1998SLR       
AP08/22/1997SLR       
AP010/28/1997SCS       
AP010/8/1998SLR       
AP03/18/1999SLR3364020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19462s27.pdf 3/18/1999
AP010/13/1999SCM       
AP011/27/2000SLR       
AP04/25/2001SLR       
AP06/6/2002SE83360024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19462s030ltr.pdf 6/6/2002
AP06/6/2002SE83361024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf 6/6/2002
AP06/6/2002SE817183024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019462_S030 & 019527_S024 & 020752_S005_Pepcid RPD_AP.pdf 7/9/2007
AP03/14/2001SLR       
AP011/24/2004SLR10654027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19527s027ltr.pdf 12/2/2004
AP011/24/2004SLR10698027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19527s027lbl.pdf 12/3/2004
AP011/5/2007SLR18339028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019527s028lbl.pdf 11/7/2007
AP011/5/2007SLR18352028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019527s028ltr.pdf 11/8/2007




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