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FDA Drug Application 021511 by ROCHE

Application Number021511
Application Type New Drug Application
Sponsor ApplicantROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/3/2002N4809000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21511ltr.pdf 12/3/2002
AP012/3/2002N4810000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21511_Copegus_lbl.pdf 12/3/2002
AP012/3/2002N7270000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088576.pdf 12/17/2003
AP012/3/2002N9973000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-511_Copegus.cfm 8/10/2004
AP05/5/2004SLR8537002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21511slr002_copegus_lbl.pdf 5/7/2004
AP05/5/2004SLR8538002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21511slr002ltr.pdf 5/7/2004
AP02/25/2005SE111196005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s005ltr.pdf 3/3/2005
AP02/25/2005SE111207005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s005lbl.pdf 3/3/2005
AP08/22/2005SLR12661006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s006lbl.pdf 8/24/2005
AP08/22/2005SLR12662006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s006ltr.pdf 8/24/2005
AP08/22/2005SLR12813006Release Letter  http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s006_rerelease_ltr.pdf 9/22/2005
AP08/22/2005SLR13013006Release 2 Letter  http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s006_rerelease2_ltr.pdf 11/1/2005
AP08/16/2005SLR12631007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s007ltr.pdf 8/19/2005
AP08/16/2005SLR12649007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s007lbl.pdf 8/19/2005
AP06/21/2005SCF11867008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s008ltr.pdf 6/23/2005
AP011/23/2005SLR13135012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021511s012lbl.pdf 11/30/2005
AP011/23/2005SLR13172012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021511s012ltr.pdf 11/30/2005
AP06/19/2007SLR16835014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021511s014lbl.pdf 6/27/2007
AP06/19/2007SLR16914014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021511s014ltr.pdf 7/5/2007
AP04/17/2008SLR19687015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021511s015ltr.pdf 4/22/2008
AP04/15/2009SLR22457016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021511s016,021511s017ltr.pdf 5/7/2009
AP04/15/2009SLR22458017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021511s016,021511s017ltr.pdf 5/7/2009
AP03/3/2010SLR24977018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s018lbl.pdf 3/5/2010
AP03/3/2010SLR24989018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021511s018ltr.pdf 3/8/2010
AP06/9/2010SLR25735019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021511s019ltr.pdf 6/15/2010
AP06/9/2010SLR25772019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s019lbl.pdf 6/24/2010
AP010/8/2010SLR26618020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s020lbl.pdf 10/12/2010
AP010/8/2010SLR26650020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021511s020ltr.pdf 10/13/2010
AP012/21/2010SE827339021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021511s021lbl.pdf 12/22/2010
AP012/21/2010SE827340021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021511s021ltr.pdf 12/22/2010
AP08/9/2011SE829733022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s022,103964s5186ltr.pdf 8/11/2011
AP08/9/2011SE829741022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021511s022lbl.pdf 8/11/2011
AP08/22/2011SLR29862023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021511s023lbl.pdf 8/24/2011
AP08/22/2011SLR29885023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s023,103964s5213ltr.pdf 8/26/2011
AP05/9/2011SLR28782024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021511s024ltr.pdf 5/11/2011
AP02/6/2013SLR35103026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021511Orig1s026ltr.pdf 2/8/2013
AP02/6/2013SLR35106026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021511s026lbl.pdf 2/8/2013
AP03/4/2014SCM       
AP08/11/2015SLR43631029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021511Orig1s029ltr.pdf 8/12/2015
AP08/11/2015SLR43636029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021511s029lbl.pdf 8/12/2015




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