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FDA Drug Application 020118 by BAXTER HLTHCARE

Application Number020118
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
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
AP09/18/1992N       
AP03/26/1993SCM       
AP07/5/1995SLR       
AP012/16/1997SCM       
AP012/9/1998SCS       
AP012/2/1999SCP       
AP08/8/2002SCP       
AP05/8/2006SLR14097010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s010lbl.pdf 5/16/2006
AP05/8/2006SLR14112010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020118s010ltr.pdf 5/16/2006
AP08/14/2006SLR14712011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s011lbl.pdf 8/18/2006
AP08/14/2006SLR14740011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020118s011LTR.pdf 8/21/2006
AP012/15/2006SE515495012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020118s012lbl.pdf 12/26/2006
AP012/15/2006SE515547012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020118s012ltr.pdf 12/28/2006
AP04/14/2009SLR22286016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020118s016ltr.pdf 4/20/2009
AP04/14/2009SLR22318016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020118s016lbl.pdf 4/23/2009
AP04/5/2010SLR25218017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020118s017lbl.pdf 4/5/2010
AP04/5/2010SLR25232017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020118s017ltr.pdf 4/8/2010
AP09/23/2013SLR37198018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020118s018lbl.pdf 9/23/2013
AP09/23/2013SLR37208018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020118Orig1s018ltr.pdf 9/24/2013
AP09/27/2013SCM       
AP02/26/2015SLR41946020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020118Orig1s020ltr.pdf 2/27/2015
AP02/26/2015SLR41972020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020118s020lbl.pdf 3/2/2015




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