Back to FDA Applications sponsored by BAXTER HLTHCARE

FDA Drug Application 016677 by BAXTER HLTHCARE

Application Number016677
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
AP012/9/1970N       
AP07/10/1975SCS       
AP09/25/1975SCS       
AP09/17/1975SCS       
AP05/11/1976SCS       
AP09/23/1975SCS       
AP010/20/1976SLR       
AP01/5/1976SCS       
AP07/1/1976SCS       
AP01/2/1976SLR       
AP06/17/1976SCS       
AP01/11/1978SCS       
AP07/13/1976SFP       
AP010/18/1976SLR       
AP01/11/1978SCS       
AP01/11/1978SCS       
AP02/7/1977SCP       
AP06/6/1977SCS       
AP012/14/1977SCS       
AP02/28/1978SCS       
AP03/24/1978SCS       
AP06/20/1978SCS       
AP02/25/1980SCS       
AP03/22/1978SCS       
AP04/25/1978SLR       
AP011/3/1978SCS       
AP08/2/1978SCS       
AP08/7/1978SCS       
AP010/20/1978SCS       
AP09/8/1978SCS       
AP03/23/1979SCE       
AP08/2/1979SCS       
AP06/28/1980SCS       
AP08/7/1980SCS       
AP02/22/1980SCS       
AP05/30/1980SCS       
AP05/30/1980SCS       
AP06/18/1980SCS       
AP04/16/1981SCS       
AP08/6/1981SCP       
AP07/31/1980SCS       
AP01/21/1981SCS       
AP06/29/1981SCS       
AP04/23/1981SCS       
AP05/20/1981SCS       
AP012/21/1981SCS       
AP08/26/1981SLR       
AP04/16/1982SCS       
AP011/9/1981SCS       
AP06/3/1982SCS       
AP011/20/1981SCS       
AP07/11/1983SPD       
AP02/16/1982SCS       
AP04/8/1982SLR       
AP01/24/1985SCS       
AP03/16/1984SCS       
AP08/28/1985SCS       
AP08/28/1985SCS       
AP02/28/1984SCS       
AP09/21/1984SCE       
AP010/30/1985SCS       
AP010/30/1985SLR       
AP09/22/1984SCS       
AP06/13/1985SCS       
AP04/15/1985SLR       
AP04/15/1985SCS       
AP02/27/1986SCP       
AP05/28/1987SCS       
AP07/25/1987SCP       
AP04/27/1987SCE       
AP01/10/1989SCS       
AP06/14/1988SCM       
AP01/12/1989SCS       
AP07/26/1989SCS       
AP02/15/1991SCS       
AP03/23/1990SCS       
AP05/24/1990SCS       
AP03/26/1991SCS       
AP011/23/1992SCM       
AP06/1/1993SCM       
AP01/6/1993SCM       
AP09/30/1994SCS       
AP02/18/1994SCS       
AP09/27/1995SCM       
AP011/14/1996SCP       
AP010/11/1996SCP       
AP06/10/1997SCM       
AP04/29/1997SCP       
AP012/31/1997SCM       
AP04/3/2002SLR3487124   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf 4/3/2002
AP011/24/1999SCM       
AP08/14/2001SCM       
AP09/16/2002SCM       
AP07/17/2003SCS6176131   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16677scs131ltr.pdf 7/28/2003
AP05/23/2005SLR11700137   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016677s137ltr.pdf 5/25/2005
AP05/23/2005SLR11710137   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016677s137lbl.pdf 5/25/2005
AP08/26/2005S12722139   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf 9/7/2005
AP08/26/2005S12723139   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf 9/7/2005
AP09/11/2013SLR37085147   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016677s147,018016s061,016693s096ltr.pdf 9/13/2013
AP09/11/2013SLR37128147   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,018016s061lbl.pdf 9/17/2013
AP012/22/2014SLR41454148   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016677Orig1s148,018016Orig1s062,019022Orig1s026ltr.pdf 12/30/2014
AP012/22/2014SLR41558148   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf 1/8/2015
AP06/5/2014SCM       
AP05/13/2015SCM42974150   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016677s150lbl.pdf 6/3/2015
AP03/3/2016SCM       




Back to FDA Applications sponsored by BAXTER HLTHCARE

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.