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FDA Drug Application 020239 by ROCHE

Application Number020239
Application Type New Drug Application
Sponsor ApplicantROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/29/1993N       
AP03/11/1994SCF       
AP01/21/1997SLR       
AP011/21/1995SLR       
AP01/21/1997SE2       
AP010/24/1996SCM       
AP05/30/1997SCF       
AP03/20/1997SLR20559007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020239_s007_KYTRIL INJ.pdf 8/11/2008
AP08/16/2002SE11997008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20239se1-008ltr.pdf 8/16/2002
AP08/16/2002SE11998008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21239s8lbl.pdf 8/16/2002
AP011/5/2002SCM       
AP011/25/2002SCS       
AP08/20/2004SCF10052015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s015ltr.pdf 8/25/2004
AP08/20/2004SCF10074015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20239s015lbl.pdf 8/25/2004
AP08/20/2004SCF21619015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020239_s015_KYTRIL INJECTION.pdf 1/12/2009
AP09/17/2004SCF23332016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020239_s016_KYTRIL.pdf 9/16/2009
AP09/17/2004SCF10237016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s016,017ltr.pdf 9/21/2004
AP09/17/2004SCM10238017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s016,017ltr.pdf 9/21/2004
AP09/17/2004SCM23333017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020239_s017_KYTRIL.pdf 9/16/2009
AP011/23/2005SLR23334018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020239_s018_Kytril Inj.pdf 9/16/2009
AP011/23/2005SLR13137018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020239s018lbl.pdf 11/30/2005
AP011/23/2005SLR13153018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020239s018ltr.pdf 11/30/2005
AP010/7/2009SLR23593021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,021238s007lbl.pdf 10/14/2009
AP010/7/2009SLR23849021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020239s021,020305s014,021238s007ltr.pdf 11/12/2009
AP04/29/2011SE828667023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020239s023lbl.pdf 5/2/2011
AP04/29/2011SE830035023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020239s023ltr.pdf 9/19/2011




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