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FDA Drug Application 050655 by BAXTER HLTHCARE

Application Number050655
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
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
AP010/31/1989N       
AP08/22/1991SLR       
AP07/17/1992SCS       
AP01/28/1992SCS       
AP03/25/1992SCE       
AP08/12/1992SLR       
AP04/3/1995SCM       
AP05/5/1995SCS       
AP08/7/1998SCM       
AP08/23/2002SLR3084012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50665slr012ltr.pdf 8/23/2002
AP08/7/2003SLR6512013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50655slr013ltr.pdf 8/15/2003
AP08/9/2006SLR14695016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050655s016LTR.pdf 8/14/2006
AP04/14/2008SLR19656017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050655s017ltr.pdf 4/16/2008
AP04/14/2008SLR19719017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050655s017lbl.pdf 4/23/2008
AP011/9/2011SLR30548018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050655s018lbl.pdf 11/10/2011
AP011/9/2011SLR30566018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050655s018ltr.pdf 11/14/2011
AP04/3/2015SLR42428023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050655Orig1s023ltr.pdf 4/6/2015
AP04/3/2015SLR42456023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050655s023lbl.pdf 4/7/2015




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