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FDA Drug Application 009170 by VALEANT

Application Number009170
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
AP03/8/1954N       
AP02/18/1981SCM       
AP01/28/1982SCS       
AP05/20/1982SCS       
AP08/11/1989SCF       
AP09/2/1987SCS       
AP07/28/1988SCP       
AP010/25/1989SCM       
AP03/18/1994SCS       
AP04/10/2000SLR       
AP012/14/2000SCM       
AP05/6/2002SCM       
AP06/13/2008SCM20014031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/009170s031ltr.pdf 6/16/2008
AP01/29/2009SCM21700033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009170s033ltr.pdf 2/3/2009
AP05/8/2009SCM22542034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009170s034ltr.pdf 5/13/2009
AP05/8/2009SCM23595034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/09170_S034lbl.pdf 10/15/2009
AP07/21/2010SLR26000035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009170s035ltr.pdf 7/23/2010
AP07/21/2010SLR26047035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009170s035MedGuide.pdf 7/30/2010
AP07/21/2010SLR26048035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009170s035lbl.pdf 7/30/2010
AP04/23/2009SLR22370036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009170s036ltr.pdf 5/1/2009
AP04/23/2009SLR22558036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009170s036lbl.pdf 5/13/2009
AP08/10/2011SLR29760038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009170s038ltr.pdf 8/12/2011
AP02/19/2016SCM       




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