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FDA Drug Application 016831 by VALEANT PHARM INTL

Application Number016831
Application Type New Drug Application
Sponsor ApplicantVALEANT PHARM INTL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/29/1970N       
AP06/30/1975SCS29233008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s008_efudex.pdf 6/23/2011
AP09/19/1974SCS       
AP05/7/1975SCS       
AP05/7/1975SCS29234011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s011_efudex.pdf 6/23/2011
AP012/14/1977SCS       
AP012/14/1977SCS       
AP011/21/1978SCM       
AP010/23/1979SCS       
AP012/18/1979SCS       
AP03/26/1987SPD       
AP03/10/1982SLR       
AP05/14/1982SCS       
AP03/14/1983SCS       
AP08/12/1983SCS       
AP08/12/1983SCS       
AP05/4/1984SCS       
AP08/13/1984SCS       
AP03/14/1985SCS       
AP06/10/1985SCP       
AP011/14/1986SCM       
AP011/30/1988SCM29235028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s028_efudex.pdf 6/23/2011
AP03/21/1995SLR       
AP03/4/1993SCS29236030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s030_efudex.pdf 6/23/2011
AP08/5/1993SCS29237031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16831_s031_efudex.pdf 6/23/2011
AP02/18/1997SCS       
AP011/2/1998SCS       
AP04/5/2000SCM29238035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/16831_s035_efudex.pdf 6/23/2011
AP07/7/2000SCM       
AP07/7/2000SCM       
AP06/20/2000SCS       
AP02/12/2001SCM       
AP07/3/2001SCS       
AP07/3/2001SCS       
AP08/30/2001SCM       
AP011/27/2002SCM       
AP04/27/2004SCM8428046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16831scm046ltr.pdf 4/29/2004
AP06/24/2004SLR9548047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16831slr047ltr.pdf 6/25/2004
AP06/24/2004SLR9563047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16831slr047_efudex_lbl.pdf 6/25/2004
AP010/13/2005SLR12894049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016831s049ltr.pdf 10/19/2005
AP010/13/2005SLR12906049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016831s049lbl.pdf 10/19/2005
AP05/10/2006SCP14108051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016831s051ltr.pdf 5/16/2006
AP012/12/2013SCM       
AP07/2/2013SCM       
AP05/6/2015SCM       
AP08/18/2015SCM       
AP011/4/2015SCM       




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