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FDA Drug Application 050759 by ROCHE PALO

Application Number050759
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/1/1998N577000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50759ltr.pdf 10/1/1998
AP010/1/1998N23632000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM170919.pdf 10/19/2009
AP010/1/1998N11972000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050759_s000_CellCeptTOC.cfm 7/11/2005
AP010/1/1998N33856000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37 9/27/2012
AP010/1/1998N22952000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm 7/15/2009
AP06/11/1999SCM       
AP04/20/2000SCS       
AP06/16/2000SCS       
AP07/27/2000SLR10377004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s004_50-723s003_50-758s003_50-759s004_CellCept.cfm 10/8/2004
AP012/20/2000SE52359005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S5ltr.pdf 12/22/2000
AP012/20/2000SE52360005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50759S5lbl.pdf 12/22/2000
AP012/20/2000SE52361005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S007_CellCept.cfm 12/22/2000
AP07/28/2000SE12369006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF 7/28/2000
AP07/28/2000SE12370006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50722005LBL.PDF 7/28/2000
AP07/28/2000SE12371006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S005_CellCept.cfm 7/28/2000
AP02/1/2001SCS       
AP02/28/2003SLR3839008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050759s008lbl.pdf 2/28/2003
AP02/28/2003SLR4249008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50759slr008,50758slr005,50723slr006,50722slr008ltr.pdf 3/10/2003
AP010/3/2001SCS       
AP011/21/2001SCS       
AP012/17/2002SCM       
AP010/17/2005SLR12893015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050722s013,050723s010,050758s012,050759s015ltr.pdf 10/19/2005
AP010/17/2005SLR12904015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050722s013,050723s010,050758s012,050759s015lbl.pdf 10/19/2005
AP012/20/2007SLR18669018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s015,050723s012,050758s013,050759s018lbl.pdf 12/27/2007
AP012/20/2007SLR18773018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s015,050723s012,050758s013,050759s018ltr.pdf 1/9/2008
AP09/21/2007SLR17993019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,50758s14,50759s19ltr.pdf 9/25/2007
AP09/21/2007SLR18026019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s16,50723s13,50758s14,50759s19lbl.pdf 9/26/2007
AP05/9/2008SLR19839021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_050758s016_050759s021ltr.pdf 5/15/2008
AP05/9/2008SLR19843021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050759s021lbl.pdf 5/16/2008
AP012/15/2008SLR21401022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019, 050723s017, 050758s017, 050759s022ltr.pdf 12/24/2008
AP012/15/2008SLR21470022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s19,050723s17,050758s17,050759s22lbl.pdf 1/2/2009
AP02/27/2009SLR21949023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,050758s018,050759s023ltr.pdf 3/5/2009
AP02/27/2009SLR22054023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s020,050723s018,050758s018,050759s023lbl.pdf 3/19/2009
AP06/18/2009SLR22810024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s021,050723s019,050758s019,050759s024ltr.pdf 6/23/2009
AP06/18/2009SLR22826024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf 6/24/2009
AP09/25/2012SLR33866025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf 9/27/2012
AP010/8/2009SLR23762028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,050758s022,050759s028ltr.pdf 11/9/2009
AP010/8/2009SLR23586028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s024,050723s023,050758s022,050759s028lbl.pdf 10/14/2009
AP06/8/2012SLR32897031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,050758s024,050759s031ltr.pdf 6/12/2012
AP06/8/2012SLR32935031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031lbl.pdf 6/18/2012
AP06/8/2012SLR32936031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031mg.pdf 6/18/2012
AP02/14/2013SCM       
AP06/22/2012SLR32998033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s028,050723s027,050758s026,050759s033ltr.pdf 6/26/2012
AP06/22/2012SLR33013033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033lbl.pdf 6/26/2012
AP06/22/2012SLR33014033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033mg.pdf 6/26/2012
AP07/24/2013SCM       
AP09/27/2013SLR37290036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf 10/1/2013
AP09/27/2013SLR37291037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf 10/1/2013
AP07/9/2015SLR43336038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050722s033,050723s032,050758s030,050759s038lbl.pdf 7/13/2015
AP07/9/2015SLR43359038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s033,050723Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf 7/14/2015
AP07/16/2015SCM       
AP011/13/2015S44524040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf 11/19/2015




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