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FDA Drug Application 020305 by ROCHE

Application Number020305
Application Type New Drug Application
Sponsor ApplicantROCHE
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
AP03/16/1995N       
AP010/6/1997SE24294001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020305a_s001.pdf 10/6/1997
AP010/24/1996SCM       
AP06/15/1998SCF       
AP07/27/1999SE1978004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20103s4ltr.pdf 7/27/1999
AP07/27/1999SE1979004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020305S004_Kytril.cfm 7/27/1999
AP011/5/2002SCM       
AP011/5/2002SCM       
AP011/25/2002SCS       
AP011/23/2005SLR13140010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020305s010,021238s005lbl.pdf 11/30/2005
AP011/23/2005SLR13155010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020305s010,021238s005ltr.pdf 11/30/2005
AP011/23/2005SLR23339010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020305_s010_Kytril Tabs.pdf 9/16/2009
AP010/7/2009SLR23592014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,021238s007lbl.pdf 10/14/2009
AP010/7/2009SLR23850014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020239s021,020305s014,021238s007ltr.pdf 11/12/2009




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