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FDA Drug Application 050475 by VALEANT PHARMS INC

Application Number050475
Application Type New Drug Application
Sponsor ApplicantVALEANT PHARMS INC
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
AP04/16/1975N       
AP01/26/1983SCM       
AP02/17/1983SCF       
AP04/24/1984SCM       
AP010/24/1984SCM       
AP09/16/1986SCM       
AP06/20/1988SCE       
AP07/16/1975SCF       
AP06/20/1975SCS       
AP01/16/1976SCS       
AP04/1/1976SCP       
AP09/16/1976SCE       
AP08/4/1976SLR       
AP010/1/1976SCP       
AP011/18/1976SCS       
AP011/18/1976SLR       
AP012/8/1976SCM       
AP04/20/1977SCM       
AP07/26/1977SLR       
AP01/17/1978SCS       
AP011/21/1980SLR       
AP04/10/1979SCF       
AP01/21/1980SCE       
AP01/4/1980SCP       
AP01/4/1980SCS       
AP011/21/1980SLR       
AP08/13/1980SLR       
AP03/2/1981SCP       
AP03/5/1981SCE       
AP07/6/1981SCE       
AP02/5/1982SCS       
AP06/28/1982SLR       
AP012/21/1982SCF       
AP012/21/1982SCE       
AP04/7/1997SCS       
AP03/26/2003SLR4663046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50475slr046_gris-peg_lbl.pdf 3/28/2003
AP03/26/2003SLR5244046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50475slr046ltr.pdf 4/14/2003
AP04/16/1998SCS       
AP012/6/2000SCM       
AP07/2/2001SCM       
AP06/3/2002SCS       
AP08/1/2002SCS       
AP01/24/2007SLR15726053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050475s053lbl.pdf 2/2/2007
AP01/24/2007SLR15751053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050475s053ltr.pdf 2/2/2007
AP010/19/2010SLR26693054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050475s054lbl.pdf 10/19/2010
AP010/19/2010SLR26732054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050475s054ltr.pdf 10/25/2010
AP05/8/2013SCM       
AP04/19/2016SLR45701057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050475s057lbl.pdf 4/20/2016
AP04/19/2016SLR45723057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050475Orig1s057ltr.pdf 4/22/2016
AP09/1/2016SCM       




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