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FDA Drug Application 017512 by BAXTER HLTHCARE

Application Number017512
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
AP09/27/1978N       
AP011/21/1978SCF       
AP08/2/1979SCS       
AP02/27/1979SLR       
AP06/28/1980SCS       
AP08/7/1980SCS       
AP06/2/1980SCS       
AP06/2/1980SLR       
AP06/2/1980SCP       
AP05/30/1980SCS       
AP06/2/1980SCS       
AP06/2/1980SLR       
AP06/2/1980SLR       
AP06/18/1980SCS       
AP04/16/1981SCS       
AP08/6/1980SCS       
AP07/16/1985SCS       
AP07/16/1985SLR       
AP07/31/1980SCS       
AP01/21/1981SCS       
AP06/29/1981SCS       
AP010/5/1981SCF       
AP010/5/1981SLR       
AP011/13/1981SCS       
AP012/21/1981SCS       
AP08/26/1981SLR       
AP04/16/1982SCS       
AP06/3/1982SCS       
AP04/9/1982SCS       
AP04/9/1982SLR       
AP011/20/1981SCS       
AP012/15/1981SCS       
AP02/16/1982SCS       
AP012/3/1982SLR       
AP012/8/1982SCS       
AP012/8/1982SLR       
AP012/8/1982SCS       
AP012/8/1982SLR       
AP01/24/1985SCS       
AP03/16/1984SCS       
AP08/28/1985SCS       
AP08/28/1985SCS       
AP011/7/1983SCS       
AP011/7/1983SLR       
AP02/28/1984SCS       
AP07/9/1984SCP       
AP07/9/1984SLR       
AP09/22/1984SCS       
AP06/13/1985SCS       
AP04/10/1985SLR       
AP08/29/1985SPD       
AP08/29/1985SPD       
AP07/16/1985SCS       
AP07/16/1985SLR       
AP04/15/1985SCS       
AP02/27/1986SCP       
AP011/18/1985SCP       
AP011/18/1985SLR       
AP09/4/1986SCP       
AP05/27/1986SCM       
AP05/28/1987SCS       
AP010/16/1989SCS       
AP010/16/1989SLR       
AP01/14/1987SCS       
AP07/25/1987SCP       
AP01/10/1989SCF       
AP01/10/1989SLR       
AP01/12/1989SCS       
AP07/26/1989SCS       
AP07/11/1990SCF       
AP07/11/1990SLR       
AP02/15/1991SCS       
AP011/28/1990SLR       
AP06/12/1992SCM       
AP06/14/1993SCM       
AP04/29/1991SCS       
AP011/23/1992SCS       
AP07/21/1995SCP       
AP07/1/1994SCS       
AP09/30/1994SCS       
AP02/18/1994SCS       
AP07/2/1996SCP       
AP01/17/1997SCP       
AP04/29/1997SCP       
AP09/20/2000SCP       
AP08/22/2001SCS       
AP09/20/2002SCP       
AP08/9/2005SLR12584104   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf 8/11/2005
AP08/9/2005SLR12583106   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf 8/11/2005
AP012/19/2008SLR21406108   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017512s108ltr.pdf 12/24/2008
AP012/19/2008SLR21449108   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017512s108lbl.pdf 1/2/2009
AP04/19/2013SLR35785113   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017512s113,020163s020,020183s019lbl.pdf 4/23/2013
AP04/19/2013SLR35835113   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017512Orig1s113,020163Orig1s020,020183Orig1s019ltr.pdf 4/24/2013
AP04/26/2013SCM       
AP09/30/2014SCM       
AP02/9/2015SLR41811118   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s118,020163Orig1s025,020183Orig1s024ltr.pdf 2/10/2015
AP02/9/2015SLR41816118   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020183s024lbl.pdf 2/10/2015
AP05/22/2015SCM       
AP07/29/2015SCM43530120   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s120s121lbl.pdf 7/30/2015
AP07/29/2015SCM43553120   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s120,s121ltr.pdf 7/31/2015
AP07/29/2015SCM43554121   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s120,s121ltr.pdf 7/31/2015
AP07/29/2015SCM43531121   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s120s121lbl.pdf 7/30/2015
AP09/1/2015SLR43797122   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s122,020163Orig1s027,020183Orig1s026ltr.pdf 9/4/2015
AP09/1/2015SLR43814122   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s122,020163s027,020183s026lbl.pdf 9/4/2015
AP08/16/2016SLR46785123   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017512s123,020163s028,020183s027lbl.pdf 8/17/2016
AP08/16/2016SLR46801123   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017512Orig1s123,020163Orig1s028,020183Orig1s027ltr.pdf 8/18/2016
AP08/1/2016SCM       




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