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FDA Drug Application 006035 by EDISON THERAPS LLC

Application Number006035
Application Type New Drug Application
Sponsor ApplicantEDISON THERAPS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/19/1946N       
AP05/20/1975SCS       
AP05/20/1975SCS       
AP01/16/1976SCS       
AP05/3/1976SCS       
AP06/9/1977SCP       
AP01/16/1979SCS       
AP01/23/1979SES       
AP05/15/1979SES       
AP07/22/1980SES       
AP06/17/1981SES       
AP09/28/1981SCS       
AP06/17/1981SCS       
AP06/15/1981SCM       
AP010/22/1984SCS       
AP08/30/1984SCS       
AP09/30/1985SPD       
AP06/18/1985SCS       
AP05/14/1985SCF       
AP01/7/1986SLR       
AP07/6/1987SCS       
AP05/6/1987SLR       
AP03/2/1989SCF       
AP010/20/1989SCF       
AP010/20/1989SCS       
AP010/20/1989SCM       
AP010/20/1989SCS       
AP09/6/1990SCS       
AP05/28/1991SLR       
AP03/22/1995SLR       
AP07/18/1994SCF       
AP04/25/1994SLR       
AP03/11/1993SCM       
AP07/7/1994SCP       
AP09/22/1995SCP       
AP09/22/1995SCS       
AP010/17/1995SCS       
AP02/22/1996SLR       
AP02/21/1996SCM       
AP05/27/1997SLR       
AP07/15/1997SCS       
AP04/22/1999SCP       
AP012/9/1999SCM       
AP04/14/2000SCM       
AP05/22/2001SCS       
AP04/3/2001SCM       
AP01/28/2002SCM       
AP02/5/2002SCM       
AP02/5/2002SCM       
AP02/18/2004SLR7783072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/06035slr072ltr.pdf 3/2/2004
AP010/1/2003SLR6737073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06035slr073ltr.pdf 10/9/2003
AP04/26/2007SLR16350075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/006035s075lbl.pdf 5/1/2007
AP04/26/2007SLR16383075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/006035s07LTRd.pdf 5/1/2007
AP06/25/2012N33001078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006035s078lbl.pdf 6/25/2012
AP06/25/2012N33031078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006035s078ltr.pdf 6/27/2012
AP06/25/2012N34990078   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/006035Orig1S078.pdf 1/28/2013
AP05/21/2013SCM       




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