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FDA Drug Application 017001 by VALEANT

Application Number017001
Application Type New Drug Application
Sponsor ApplicantVALEANT
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
AP011/26/1971N       
AP05/13/1977SCS       
AP08/11/1977SCF       
AP01/3/1978SCS       
AP08/24/1978SCF       
AP011/26/1979SCS       
AP04/23/1981SCS       
AP06/1/1987SPD       
AP01/27/1982SCS       
AP012/6/1982SCS       
AP012/21/1983SCS       
AP08/8/1984SCP       
AP04/30/2003SLR5578019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017001s019lbl.pdf 5/6/2003
AP04/30/2003SLR5739019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/170001slr019,020ltr.pdf 5/29/2003
AP04/30/2003SLR5740020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/170001slr019,020ltr.pdf 5/29/2003
AP04/30/2003SLR5577020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/017001s019lbl.pdf 5/6/2003
AP07/31/1997SCM       
AP08/27/1997SCP       
AP09/29/1999SCS       
AP02/3/2000SCM       
AP08/10/2006SLR14657027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017001s027lbl.pdf 8/11/2006
AP08/10/2006SLR14674027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017001s027LTR.pdf 8/11/2006
AP05/4/2009SLR22456028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017001s028ltr.pdf 5/7/2009
AP01/8/2014SCM       
AP02/5/2016SCM       




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