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FDA Drug Application 050723 by ROCHE PALO

Application Number050723
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/19/1997N22950000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm 7/15/2009
AP06/19/1997N23630000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM170919.pdf 10/19/2009
AP06/19/1997N33854000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37 9/27/2012
AP02/11/1998SLR       
AP06/16/2000SCS       
AP07/27/2000SLR10375003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s004_50-723s003_50-758s003_50-759s004_CellCept.cfm 10/8/2004
AP012/20/2000SE52356004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S5ltr.pdf 12/22/2000
AP012/20/2000SE52357004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50759S5lbl.pdf 12/22/2000
AP012/20/2000SE52358004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S007_CellCept.cfm 12/22/2000
AP07/28/2000SE12363005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF 7/28/2000
AP07/28/2000SE12364005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50722005LBL.PDF 7/28/2000
AP07/28/2000SE12365005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S005_CellCept.cfm 7/28/2000
AP02/28/2003SLR3844006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050759s008lbl.pdf 2/28/2003
AP02/28/2003SLR4251006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50759slr008,50758slr005,50723slr006,50722slr008ltr.pdf 3/10/2003
AP012/17/2002SCM       
AP010/17/2005SLR12891010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050722s013,050723s010,050758s012,050759s015ltr.pdf 10/19/2005
AP010/17/2005SLR12903010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050722s013,050723s010,050758s012,050759s015lbl.pdf 10/19/2005
AP012/20/2007SLR18671012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s015,050723s012,050758s013,050759s018lbl.pdf 12/27/2007
AP012/20/2007SLR18771012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s015,050723s012,050758s013,050759s018ltr.pdf 1/9/2008
AP09/21/2007SLR17991013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,50758s14,50759s19ltr.pdf 9/25/2007
AP09/21/2007SLR18028013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s16,50723s13,50758s14,50759s19lbl.pdf 9/26/2007
AP05/9/2008SLR19837015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_050758s016_050759s021ltr.pdf 5/15/2008
AP05/9/2008SLR19841015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050723s015lbl.pdf 5/16/2008
AP012/15/2008SLR21399017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019, 050723s017, 050758s017, 050759s022ltr.pdf 12/24/2008
AP012/15/2008SLR21468017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s19,050723s17,050758s17,050759s22lbl.pdf 1/2/2009
AP02/27/2009SLR21947018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,050758s018,050759s023ltr.pdf 3/5/2009
AP02/27/2009SLR22056018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s020,050723s018,050758s018,050759s023lbl.pdf 3/19/2009
AP06/18/2009SLR22808019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s021,050723s019,050758s019,050759s024ltr.pdf 6/23/2009
AP06/18/2009SLR22824019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf 6/24/2009
AP09/25/2012SLR33864020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf 9/27/2012
AP07/22/2009SCM24051021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050723s021ltr.pdf 11/20/2009
AP010/8/2009SLR23760023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,050758s022,050759s028ltr.pdf 11/9/2009
AP010/8/2009SLR23588023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s024,050723s023,050758s022,050759s028lbl.pdf 10/14/2009
AP06/8/2012SLR32899025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,050758s024,050759s031ltr.pdf 6/12/2012
AP06/8/2012SLR32939025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031mg.pdf 6/18/2012
AP06/8/2012SLR32940025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031lbl.pdf 6/18/2012
AP02/14/2013SCM       
AP06/22/2012SLR32996027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s028,050723s027,050758s026,050759s033ltr.pdf 6/26/2012
AP06/22/2012SLR33017027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033lbl.pdf 6/26/2012
AP06/22/2012SLR33018027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033mg.pdf 6/26/2012
AP09/27/2013SLR37286029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf 10/1/2013
AP09/27/2013SLR37306029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf 10/1/2013
AP09/27/2013SLR37307030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf 10/1/2013
AP09/27/2013SLR37287030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf 10/1/2013
AP01/23/2014SCM       
AP07/9/2015SLR43338032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050722s033,050723s032,050758s030,050759s038lbl.pdf 7/13/2015
AP07/9/2015SLR43357032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s033,050723Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf 7/14/2015
AP011/13/2015S44522033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf 11/19/2015




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