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FDA Drug Application 016721 by VALEANT PHARM INTL

Application Number016721
Application Type New Drug Application
Sponsor ApplicantVALEANT PHARM INTL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/7/1970N16047000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm 3/16/2007
AP04/7/1970N23943000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf 11/18/2009
AP04/22/1974SF       
AP09/17/1974SCS       
AP01/16/1975SCS       
AP07/1/1975SCS       
AP07/10/1978SLR       
AP012/10/1976SLR       
AP08/2/1977SDS       
AP06/29/1977SCS       
AP07/12/1977SCF       
AP05/2/1978SCM       
AP07/10/1978SLR       
AP07/20/1978SLR       
AP07/12/1978SCF       
AP07/28/1978SCF       
AP03/26/1979SCF       
AP05/1/1979SCF       
AP09/17/1979SCM       
AP011/9/1979SCM       
AP02/4/1980SCM       
AP06/17/1980SCP       
AP06/17/1980SCF       
AP07/11/1980SCP       
AP08/20/1980SCS       
AP08/20/1980SCS       
AP05/6/1981SLR       
AP03/26/1981SCS       
AP07/17/1981SCP       
AP08/4/1981SCP       
AP011/5/1981SCM       
AP012/22/1981SCS       
AP012/22/1981SCS       
AP01/28/1982SCP       
AP06/15/1982SCF       
AP012/11/1984SCP       
AP011/9/1987SLR       
AP011/7/1989SCP       
AP01/16/1990SCM       
AP04/25/1990SCS       
AP012/31/1992SCS       
AP05/25/1993SCF       
AP06/14/2001SLR5113074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16721s74ltr.pdf 6/14/2001
AP08/12/2002SCM       
AP010/30/2007SLR18331076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016721s076lbl.pdf 11/7/2007
AP010/30/2007SLR18379076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016721s076,s058ltr.pdf 11/8/2007
AP03/27/2009SLR22139077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016721s077ltr.pdf 4/1/2009
AP03/27/2009SLR22178077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf 4/3/2009




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