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FDA Drug Application 020610 by VALEANT PHARMS INTL

Application Number020610
Application Type New Drug Application
Sponsor ApplicantVALEANT PHARMS INTL
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
AP07/18/2000N2535000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-610_Colazal.cfm 7/18/2000
AP07/18/2000N81000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20610ltr.pdf 7/18/2000
AP07/18/2000N82000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20610lbl.pdf 7/18/2000
AP06/18/2002SLR2533001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20610s001ltr.pdf 6/18/2002
AP02/7/2002SCM       
AP03/10/2006SCP13806013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020610s013ltr.pdf 3/23/2006
AP09/21/2006SLR14952014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020610s014ltr.pdf 9/25/2006
AP09/21/2006SLR14970014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020610s014lbl.pdf 9/25/2006
AP012/20/2006SE515517016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020610s016lbl.pdf 12/28/2006
AP012/20/2006SE515522016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020610s016ltr.pdf 12/28/2006
AP011/2/2007SLR18337017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020610s017lbl.pdf 11/7/2007
AP011/2/2007SLR18360017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020610s017ltr.pdf 11/8/2007
AP07/9/2008SLR20199018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020610s018ltr.pdf 7/14/2008
AP03/5/2014SCM       
AP01/5/2015SCM       




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