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FDA Drug Application 050638 by BAXTER HLTHCARE

Application Number050638
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
AP06/25/1990N       
AP011/3/1992SCS       
AP011/19/1991SLR       
AP010/31/1994SCS       
AP07/20/1999SLR       
AP08/23/2002SLR3137007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50638slr007ltr.pdf 8/23/2002
AP011/7/2000SCP       
AP06/10/2004SLR9380010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50638slr010ltr.pdf 6/15/2004
AP02/4/2005SLR11087011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50638s011ltr.pdf 2/8/2005
AP03/1/2008SLR19363012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050638s012lbl.pdf 3/5/2008
AP03/1/2008SLR19385012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050638s012ltr.pdf 3/5/2008
AP04/16/2012SLR32456016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050638s016lbl.pdf 4/16/2012
AP04/16/2012SLR32463016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050638s016ltr.pdf 4/18/2012
AP03/19/2014SCM       
AP07/18/2016SLR46556019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050638Orig1s019ltr.pdf 7/20/2016
AP07/18/2016SLR46586019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050638s019lbl.pdf 7/21/2016




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