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FDA Drug Application 050722 by ROCHE PALO

Application Number050722
Application Type New Drug Application
Sponsor ApplicantROCHE PALO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/3/1995N22949000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm 7/15/2009
AP05/3/1995N23629000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM170919.pdf 10/19/2009
AP05/3/1995N33853000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37 9/27/2012
AP06/12/1997SCS       
AP02/11/1998SE1       
AP04/13/1998SCM       
AP07/27/2000SLR10374004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s004_50-723s003_50-758s003_50-759s004_CellCept.cfm 10/8/2004
AP07/28/2000SE11432005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF 7/28/2000
AP07/28/2000SE11433005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50722005LBL.PDF 7/28/2000
AP07/28/2000SE12362005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S005_CellCept.cfm 7/28/2000
AP05/15/2000SCS10378006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s006_CellCept.cfm 10/8/2004
AP012/20/2000SE51521007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S5ltr.pdf 12/20/2000
AP012/20/2000SE51522007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50759S5lbl.pdf 12/20/2000
AP012/20/2000SE52355007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S007_CellCept.cfm 12/22/2000
AP02/28/2003SLR3845008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050759s008lbl.pdf 2/28/2003
AP02/28/2003SLR4252008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50759slr008,50758slr005,50723slr006,50722slr008ltr.pdf 3/10/2003
AP011/14/2001SCP10379009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50-722s009_CellCept.cfm 10/8/2004
AP05/31/2002SCM       
AP010/17/2005SLR12890013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050722s013,050723s010,050758s012,050759s015ltr.pdf 10/19/2005
AP010/17/2005SLR12902013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050722s013,050723s010,050758s012,050759s015lbl.pdf 10/19/2005
AP012/20/2007SLR18672015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s015,050723s012,050758s013,050759s018lbl.pdf 12/27/2007
AP012/20/2007SLR18770015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s015,050723s012,050758s013,050759s018ltr.pdf 1/9/2008
AP09/21/2007SLR17990016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,50758s14,50759s19ltr.pdf 9/25/2007
AP09/21/2007SLR18029016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s16,50723s13,50758s14,50759s19lbl.pdf 9/26/2007
AP05/9/2008SLR19835018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_050758s016_050759s021ltr.pdf 5/15/2008
AP05/9/2008SLR19840018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s018lbl.pdf 5/16/2008
AP012/15/2008SLR21398019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019, 050723s017, 050758s017, 050759s022ltr.pdf 12/24/2008
AP012/15/2008SLR21467019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s19,050723s17,050758s17,050759s22lbl.pdf 1/2/2009
AP02/27/2009SLR21946020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,050758s018,050759s023ltr.pdf 3/5/2009
AP02/27/2009SLR22057020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s020,050723s018,050758s018,050759s023lbl.pdf 3/19/2009
AP06/18/2009SLR22807021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s021,050723s019,050758s019,050759s024ltr.pdf 6/23/2009
AP06/18/2009SLR22823021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf 6/24/2009
AP09/25/2012SLR33863022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf 9/27/2012
AP010/8/2009SLR23589024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s024,050723s023,050758s022,050759s028lbl.pdf 10/14/2009
AP010/8/2009SLR23759024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,050758s022,050759s028ltr.pdf 11/9/2009
AP06/8/2012SLR32900026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,050758s024,050759s031ltr.pdf 6/12/2012
AP06/8/2012SLR32941026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031lbl.pdf 6/18/2012
AP06/8/2012SLR32942026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031mg.pdf 6/18/2012
AP02/14/2013SCM       
AP06/22/2012SLR32995028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s028,050723s027,050758s026,050759s033ltr.pdf 6/26/2012
AP06/22/2012SLR33019028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033mg.pdf 6/26/2012
AP06/22/2012SLR33020028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033lbl.pdf 6/26/2012
AP09/27/2013SLR37284030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf 10/1/2013
AP09/27/2013SLR37308030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf 10/1/2013
AP09/27/2013SLR37285031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf 10/1/2013
AP09/27/2013SLR37309031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf 10/1/2013
AP01/23/2014SCM       
AP07/9/2015SLR43339033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050722s033,050723s032,050758s030,050759s038lbl.pdf 7/13/2015
AP07/9/2015SLR43356033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s033,050723Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf 7/14/2015
AP011/13/2015S44521034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf 11/19/2015




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