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FDA Drug Application 019645 by ROCHE PALO

Application Number019645
Application Type New Drug Application
Sponsor ApplicantROCHE PALO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/20/1991N24195000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089165.pdf 12/4/2009
AP09/18/1992SCM       
AP010/11/2001SLR       
AP012/7/1994SLR       
AP010/11/2001SLR       
AP010/11/2001SLR       
AP010/11/2001SLR       
AP010/11/2001SLR       
AP010/11/2001SLR       
AP01/19/2007SLR15697016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s016lbl.pdf 1/24/2007
AP01/19/2007SLR15706016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019645s016ltr.pdf 1/25/2007
AP011/13/2007SLR18425017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019645s017lbl.pdf 11/19/2007
AP011/13/2007SLR18453017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019645s017ltr.pdf 11/19/2007
AP012/16/2008SLR21380018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019645s018ltr.pdf 12/19/2008
AP03/26/2013SLR35556019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019645Orig1s019ltr.pdf 3/28/2013
AP03/26/2013SLR35597019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019645s019lbl.pdf 4/1/2013




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