Back to FDA Applications sponsored by BAXTER HLTHCARE

FDA Drug Application 016679 by BAXTER HLTHCARE

Application Number016679
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
AP03/22/1971N       
AP07/10/1975SCS       
AP09/25/1975SCS       
AP09/17/1975SCS       
AP05/11/1976SLR       
AP09/23/1975SCS       
AP011/16/1976SLR       
AP01/5/1976SCS       
AP07/1/1976SCS       
AP01/2/1976SLR       
AP06/17/1976SCS       
AP07/13/1976SFP       
AP02/7/1977SCP       
AP06/6/1977SCS       
AP012/14/1977SCS       
AP02/28/1978SCS       
AP02/21/1978SCS       
AP03/24/1978SCS       
AP06/20/1978SCS       
AP02/25/1980SCS       
AP03/22/1978SCS       
AP04/25/1978SLR       
AP08/2/1978SCS       
AP08/7/1978SCS       
AP010/20/1978SCS       
AP010/12/1978SCS       
AP08/2/1979SCS       
AP06/28/1980SCS       
AP08/7/1980SCS       
AP05/30/1980SCS       
AP06/18/1980SCS       
AP04/16/1981SCS       
AP08/6/1980SCS       
AP07/31/1980SCS       
AP01/21/1981SCS       
AP06/29/1981SCS       
AP012/21/1981SCS       
AP08/26/1981SLR       
AP07/15/1981SCS       
AP04/16/1982SCS       
AP011/9/1981SCS       
AP06/3/1982SCS       
AP011/20/1981SCS       
AP07/11/1983SPD       
AP02/16/1982SCS       
AP01/24/1985SCS       
AP03/16/1984SCS       
AP08/28/1985SCS       
AP08/28/1985SCS       
AP02/28/1984SCS       
AP09/22/1984SCS       
AP06/13/1985SCS       
AP07/3/1985SLR       
AP04/15/1985SCS       
AP02/27/1986SCP       
AP05/28/1987SCS       
AP07/25/1987SCP       
AP07/26/1989SCS       
AP02/15/1991SCS       
AP01/10/1991SCS       
AP03/26/1991SCS       
AP04/29/1991SCS       
AP09/30/1994SCS       
AP02/18/1994SCS       
AP010/11/1996SCP       
AP04/29/1997SCP       
AP011/29/2000SLR       
AP011/24/1999SCM       
AP011/2/2000SLR       
AP08/14/2001SCM       
AP05/12/2004SLR8677096   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16679slr096ltr.pdf 5/27/2004
AP010/19/2011SLR30387104   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016679s104,016682s105,016692s095,019367s026ltr.pdf 10/24/2011
AP010/19/2011SLR30507104   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf 11/4/2011
AP011/6/2013SCM       
AP04/26/2013SCM       
AP09/30/2014SCM       
AP02/3/2015SCM       
AP01/19/2016SCM       




Back to FDA Applications sponsored by BAXTER HLTHCARE