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FDA Drug Application 021097 by SALIX PHARMS

Application Number021097
Application Type New Drug Application
Sponsor ApplicantSALIX PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/21/2000N1214000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21097ltr.pdf 9/21/2000
AP09/21/2000N1215000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21097lbl.pdf 9/21/2000
AP09/21/2000N2802000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21097_Visicol.cfm 9/21/2000
AP09/21/2000N15084000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103354.htm 10/11/2006
AP09/21/2000N35478000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM134684.pdf 3/19/2013
AP011/22/2000SCE       
AP04/2/2001SCE       
AP03/30/2001SCS       
AP09/26/2001SCE       
AP03/12/2002SCF2801005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21097s005ltr.pdf 3/12/2002
AP09/4/2002SCP       
AP02/10/2005SLR11114007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21097s007,009ltr.pdf 2/11/2005
AP02/10/2005SCP11113009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21097s007,009ltr.pdf 2/11/2005
AP03/31/2006SLR13886010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021097s010ltr.pdf 4/7/2006
AP03/31/2006SLR14038010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021097s10lblM.pdf 5/2/2006
AP03/25/2009SLR22117013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s013lbl.pdf 3/26/2009
AP03/25/2009SLR22130013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s013,021892s003ltr.pdf 3/27/2009
AP010/13/2009SLR23575014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s014MEDGUIDE.pdf 10/14/2009
AP010/13/2009SLR23576014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s014,021892s004lbl.pdf 10/14/2009
AP010/13/2009SLR24145014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s014,021892s004ltr.pdf 11/25/2009
AP010/13/2009SLR30820014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021097Orig1s014.pdf 10/10/2011
AP012/9/2011SLR30963015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021892s009,021097s015ltr.pdf 12/14/2011
AP03/7/2013SLR35373016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021097Orig1s016ltr.pdf 3/8/2013
AP03/7/2013SLR35378016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021097s016lbl.pdf 3/8/2013




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