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FDA Drug Application 020813 by ROCHE

Application Number020813
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
AP012/23/1997N26588000REMS  http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM227954.pdf 10/1/2010
AP012/23/1997N37751000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM225680.pdf 11/8/2013
AP07/31/2001SCM       
AP012/3/2001SCM       
AP04/23/2009SLR22376005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017533s045,020813s005ltr.pdf 5/1/2009
AP04/23/2009SLR22529005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017533s045,020813s005lbl.pdf 5/12/2009
AP09/1/2010SLR26399006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007MedGuide.pdf 9/7/2010
AP09/1/2010SLR26405006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf 9/7/2010
AP09/1/2010SLR26521006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017533s046,s048,020813s006,s007ltr.pdf 9/21/2010
AP09/1/2010SLR26522007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017533s046,s048,020813s006,s007ltr.pdf 9/21/2010
AP09/1/2010SLR26406007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf 9/7/2010
AP09/1/2010SLR26400007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007MedGuide.pdf 9/7/2010
AP011/29/2011SLR30877008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017533s046,020813s008ltr.pdf 12/5/2011
AP010/31/2013SLR37671009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017533s053,020813s009lbl.pdf 11/1/2013
AP010/31/2013SLR37712009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017533Orig1s053,020813Orig1s009ltr.pdf 11/6/2013




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