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FDA Drug Application 021321 by BAXTER HLTHCARE

Application Number021321
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 CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/20/2002N5081000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21321_Extraneal_lbl.pdf 4/9/2003
AP012/20/2002N5482000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21321_Extraneal.cfm 4/25/2003
AP012/20/2002N8977000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21321ltr.pdf 6/3/2004
AP012/20/2002N23957000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135933.pdf 11/18/2009
AP012/20/2002N28339000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=18 3/25/2011
AP05/24/2005SCP11707008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021321s008ltr.pdf 5/25/2005
AP05/24/2005SLR11708009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021321s009ltr.pdf 5/25/2005
AP012/17/2004SE110849010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21321s010ltr.pdf 12/30/2004
AP012/17/2004SE110887010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21321s010lbl.pdf 12/30/2004
AP02/23/2007SLR15956013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021321s013ltr.pdf 3/6/2007
AP04/7/2009SLR22265017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021321s017ltr.pdf 4/15/2009
AP04/7/2009SLR22275017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021321s017lbl.pdf 4/16/2009
AP01/29/2009SCP21705018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021321s018ltr.pdf 2/3/2009
AP03/9/2011SLR28206020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021321s020,s021ltr.pdf 3/10/2011
AP03/9/2011SLR28231020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf 3/11/2011
AP03/9/2011SLR28209021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021321s020,s021ltr.pdf 3/10/2011
AP03/9/2011SLR28230021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf 3/11/2011
AP04/26/2013SCM       
AP012/9/2014SLR41211028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021321Orig1s028ltr.pdf 12/11/2014
AP02/25/2014SLR38603029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021321Orig1s029ltr.pdf 2/27/2014
AP02/4/2014SCM       
AP010/16/2015SLR44238032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021321Orig1s032ltr.pdf 10/21/2015
AP010/16/2015SLR44265032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021321s032lbl.pdf 10/22/2015
AP08/1/2016SCM       
AP010/24/2016S47435035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021321Orig1s035ltr.pdf 10/25/2016




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