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FDA Drug Application 017521 by BAXTER HLTHCARE

Application Number017521
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/28/1979N       
AP07/18/1980SCS       
AP07/18/1980SLR       
AP05/30/1980SCS       
AP06/18/1980SCS       
AP02/11/1980SCS       
AP04/16/1981SCS       
AP08/6/1980SCS       
AP07/31/1980SCS       
AP09/9/1980SCS       
AP09/9/1980SLR       
AP01/21/1981SCS       
AP06/29/1981SCS       
AP03/26/1982SCS       
AP03/26/1982SLR       
AP012/21/1981SCS       
AP08/26/1981SLR       
AP04/16/1982SCS       
AP011/9/1981SCS       
AP06/3/1982SCS       
AP011/20/1981SCS       
AP02/16/1982SCS       
AP01/24/1985SCS       
AP03/16/1984SCS       
AP02/28/1984SCS       
AP08/24/1984SPF       
AP09/22/1984SCS       
AP06/13/1985SCS       
AP09/21/1984SCS       
AP04/15/1985SCS       
AP04/23/1985SLR       
AP012/9/1987SCP       
AP01/12/1989SCS       
AP07/26/1989SCS       
AP02/15/1991SCS       
AP05/18/1990SCS       
AP01/5/1995SCS       
AP01/5/1995SLR       
AP03/26/1991SCS       
AP07/13/1993SCM       
AP09/30/1994SCS       
AP02/18/1994SCS       
AP04/29/1997SCP       
AP06/22/1998SCS       
AP05/25/1999SCM       
AP011/24/1999SCM       
AP012/7/2000SE8       
AP011/14/2002SLR6299062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17521slr062ltr.pdf 7/31/2003
AP011/14/2002SLR17923062   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017521_s062_s063_DEXTROSE_INJ.pdf 9/24/2007
AP011/14/2002SLR17924063   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017521_s062_s063_DEXTROSE_INJ.pdf 9/24/2007
AP011/14/2002SLR6300063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17521slr062ltr.pdf 7/31/2003
AP08/14/2001SCM       
AP012/22/2014SLR41409068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016673Orig1s147,016694Orig1s119,017521Orig1s068,020047Orig1s020ltr.pdf 12/24/2014
AP012/22/2014SLR41590068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf 1/9/2015
AP02/3/2015SCM       
AP01/15/2016SCM       
AP03/23/2016SCM       




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