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FDA Drug Application 018602 by VALEANT INTL

Application Number018602
Application Type New Drug Application
Sponsor ApplicantVALEANT INTL
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
AP011/5/1982N       
AP03/11/1983SCF       
AP03/11/1983SCP       
AP05/27/1983SCP       
AP05/27/1983SCM       
AP010/6/1983SCS       
AP010/6/1983SCS       
AP09/6/1983SCE       
AP06/8/1984SCS       
AP02/28/1984SCE       
AP06/8/1984SCF       
AP07/28/1986SE2       
AP02/4/1985SCS       
AP06/20/1985SCP       
AP012/8/1986SE5       
AP07/28/1986SLR       
AP07/1/1993SE1       
AP010/29/1987SLR       
AP012/7/1987SCS       
AP011/30/1987SCE       
AP02/19/1988SCM       
AP02/19/1988SCF       
AP08/12/1988SCP       
AP010/13/1988SLR       
AP012/14/1988SCS       
AP04/12/1990SCS       
AP011/21/1989SCP       
AP012/18/1989SCP       
AP03/14/1991SCM       
AP06/13/1991SLR       
AP05/27/1992SCS       
AP010/12/1994SLR       
AP04/13/1993SCS       
AP02/8/1993SCP       
AP07/7/1993SCM       
AP012/28/1994SCP       
AP09/21/1994SCM       
AP05/4/1995SCF       
AP011/29/1994SCS       
AP012/30/1994SCS       
AP08/29/1995SCS       
AP04/2/1996SLR       
AP04/2/1996SLR       
AP08/4/1997SCS       
AP011/19/1997SCS       
AP02/5/1998SCM       
AP03/21/2003SLR       
AP06/18/1999SCS       
AP06/4/2001SCS       
AP011/23/2010SLR27064063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018602s063lbl.pdf 11/22/2010
AP011/23/2010SLR27075063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018602s063ltr.pdf 11/30/2010
AP06/24/2014SCM       
AP011/21/2014SLR41083065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018602s065lbl.pdf 11/25/2014
AP08/2/2016SCM       




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