Back to FDA Applications sponsored by ROCHE PALO

FDA Drug Application 050758 by ROCHE PALO

Application Number050758
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
AP08/12/1998N576000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/505758.cfm 8/12/1998
AP08/12/1998N22951000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm 7/15/2009
AP08/12/1998N23631000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM170919.pdf 10/19/2009
AP08/12/1998N33855000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37 9/27/2012
AP04/20/2000SCM       
AP06/16/2000SCS       
AP07/27/2000SLR10376003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s004_50-723s003_50-758s003_50-759s004_CellCept.cfm 10/8/2004
AP07/28/2000SE12366004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF 7/28/2000
AP07/28/2000SE12367004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50722005LBL.PDF 7/28/2000
AP07/28/2000SE12368004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S005_CellCept.cfm 7/28/2000
AP02/28/2003SLR3841005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050759s008lbl.pdf 2/28/2003
AP02/28/2003SLR4250005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50759slr008,50758slr005,50723slr006,50722slr008ltr.pdf 3/10/2003
AP02/27/2002SCS       
AP012/17/2002SCM       
AP04/12/2005SLR11433010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050758s010lbl.pdf 4/19/2005
AP04/12/2005SLR11434010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050758s010ltr.pdf 4/19/2005
AP010/17/2005SLR12892012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050722s013,050723s010,050758s012,050759s015ltr.pdf 10/19/2005
AP010/17/2005SLR12905012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050722s013,050723s010,050758s012,050759s015lbl.pdf 10/19/2005
AP012/20/2007SLR18670013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s015,050723s012,050758s013,050759s018lbl.pdf 12/27/2007
AP012/20/2007SLR18772013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s015,050723s012,050758s013,050759s018ltr.pdf 1/9/2008
AP09/21/2007SLR17992014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,50758s14,50759s19ltr.pdf 9/25/2007
AP09/21/2007SLR18027014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s16,50723s13,50758s14,50759s19lbl.pdf 9/26/2007
AP05/9/2008SLR19838016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_050758s016_050759s021ltr.pdf 5/15/2008
AP05/9/2008SLR19842016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050758s016lbl.pdf 5/16/2008
AP012/15/2008SLR21400017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019, 050723s017, 050758s017, 050759s022ltr.pdf 12/24/2008
AP012/15/2008SLR21469017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s19,050723s17,050758s17,050759s22lbl.pdf 1/2/2009
AP02/27/2009SLR21948018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,050758s018,050759s023ltr.pdf 3/5/2009
AP02/27/2009SLR22055018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s020,050723s018,050758s018,050759s023lbl.pdf 3/19/2009
AP06/18/2009SLR22809019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s021,050723s019,050758s019,050759s024ltr.pdf 6/23/2009
AP06/18/2009SLR22825019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf 6/24/2009
AP09/25/2012SLR33865020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf 9/27/2012
AP010/8/2009SLR23587022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s024,050723s023,050758s022,050759s028lbl.pdf 10/14/2009
AP010/8/2009SLR23761022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,050758s022,050759s028ltr.pdf 11/9/2009
AP06/8/2012SLR32898024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,050758s024,050759s031ltr.pdf 6/12/2012
AP06/8/2012SLR32937024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031lbl.pdf 6/18/2012
AP06/8/2012SLR32938024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031mg.pdf 6/18/2012
AP02/14/2013SCM       
AP06/22/2012SLR32997026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s028,050723s027,050758s026,050759s033ltr.pdf 6/26/2012
AP06/22/2012SLR33015026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033mg.pdf 6/26/2012
AP06/22/2012SLR33016026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033lbl.pdf 6/26/2012
AP09/27/2013SLR37288028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf 10/1/2013
AP09/27/2013SLR37304028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf 10/1/2013
AP09/27/2013SLR37289029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf 10/1/2013
AP09/27/2013SLR37305029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf 10/1/2013
AP07/9/2015SLR43337030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050722s033,050723s032,050758s030,050759s038lbl.pdf 7/13/2015
AP07/9/2015SLR43358030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s033,050723Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf 7/14/2015
AP011/13/2015S44523031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf 11/19/2015
AP05/26/2016SCM       




Back to FDA Applications sponsored by ROCHE PALO