Back to FDA Applications sponsored by ATON

FDA Drug Application 016092 by ATON

Application Number016092
Application Type New Drug Application
Sponsor ApplicantATON
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/10/1967N       
AP02/9/1976SCS       
AP03/21/1977SCS       
AP02/22/1978SCP       
AP03/9/1979SCS       
AP06/21/1979SCS       
AP011/29/1979SLR       
AP01/25/1980SLR       
AP01/22/1981SCF       
AP011/14/1980SCP       
AP02/19/1981SCF       
AP01/16/1981SLR       
AP09/4/1981SCF       
AP05/13/1985SPD       
AP06/17/1981SCP       
AP05/19/1983SCS       
AP09/20/1983SCS       
AP08/28/1984SLR       
AP01/13/1986SLR       
AP03/21/1986SLR       
AP08/15/1988SCS       
AP09/6/1988SCM       
AP08/7/1991SCM       
AP09/26/1994SCM       
AP03/24/1995SLR       
AP06/24/1996SCS       
AP011/3/1997SLR       
AP010/19/1999SLR1744037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/16092s037_Edecrin.pdf 10/19/1999
AP08/14/1998SCS       
AP02/3/2004SLR7776039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16092slr039,16093slr043ltr.pdf 3/2/2004
AP02/9/2005SLR11103042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16092s042,16093s044ltr.pdf 2/11/2005
AP02/9/2005SLR11106042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16092s042,16093s044lbl.pdf 2/11/2005
AP03/30/2015SCM       




Back to FDA Applications sponsored by ATON