Action Type | Duplicate Counter | Action Date | Document Type | Application Document ID | Sequence Number | Document Title | Document URL | Document Date |
AP | 0 | 5/3/1995 | N | 22949 | 000 | |
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm
| 7/15/2009 |
AP | 0 | 5/3/1995 | N | 23629 | 000 | |
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM170919.pdf
| 10/19/2009 |
AP | 0 | 5/3/1995 | N | 33853 | 000 | REMS |
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37
| 9/27/2012 |
AP | 0 | 6/12/1997 | SCS | | | |
| |
AP | 0 | 2/11/1998 | SE1 | | | |
| |
AP | 0 | 4/13/1998 | SCM | | | |
| |
AP | 0 | 7/27/2000 | SLR | 10374 | 004 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s004_50-723s003_50-758s003_50-759s004_CellCept.cfm
| 10/8/2004 |
AP | 0 | 7/28/2000 | SE1 | 1432 | 005 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF
| 7/28/2000 |
AP | 0 | 7/28/2000 | SE1 | 1433 | 005 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50722005LBL.PDF
| 7/28/2000 |
AP | 0 | 7/28/2000 | SE1 | 2362 | 005 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S005_CellCept.cfm
| 7/28/2000 |
AP | 0 | 5/15/2000 | SCS | 10378 | 006 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s006_CellCept.cfm
| 10/8/2004 |
AP | 0 | 12/20/2000 | SE5 | 1521 | 007 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S5ltr.pdf
| 12/20/2000 |
AP | 0 | 12/20/2000 | SE5 | 1522 | 007 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50759S5lbl.pdf
| 12/20/2000 |
AP | 0 | 12/20/2000 | SE5 | 2355 | 007 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S007_CellCept.cfm
| 12/22/2000 |
AP | 0 | 2/28/2003 | SLR | 3845 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050759s008lbl.pdf
| 2/28/2003 |
AP | 0 | 2/28/2003 | SLR | 4252 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50759slr008,50758slr005,50723slr006,50722slr008ltr.pdf
| 3/10/2003 |
AP | 0 | 11/14/2001 | SCP | 10379 | 009 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50-722s009_CellCept.cfm
| 10/8/2004 |
AP | 0 | 5/31/2002 | SCM | | | |
| |
AP | 0 | 10/17/2005 | SLR | 12890 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050722s013,050723s010,050758s012,050759s015ltr.pdf
| 10/19/2005 |
AP | 0 | 10/17/2005 | SLR | 12902 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050722s013,050723s010,050758s012,050759s015lbl.pdf
| 10/19/2005 |
AP | 0 | 12/20/2007 | SLR | 18672 | 015 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s015,050723s012,050758s013,050759s018lbl.pdf
| 12/27/2007 |
AP | 0 | 12/20/2007 | SLR | 18770 | 015 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s015,050723s012,050758s013,050759s018ltr.pdf
| 1/9/2008 |
AP | 0 | 9/21/2007 | SLR | 17990 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,50758s14,50759s19ltr.pdf
| 9/25/2007 |
AP | 0 | 9/21/2007 | SLR | 18029 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s16,50723s13,50758s14,50759s19lbl.pdf
| 9/26/2007 |
AP | 0 | 5/9/2008 | SLR | 19835 | 018 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_050758s016_050759s021ltr.pdf
| 5/15/2008 |
AP | 0 | 5/9/2008 | SLR | 19840 | 018 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s018lbl.pdf
| 5/16/2008 |
AP | 0 | 12/15/2008 | SLR | 21398 | 019 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019, 050723s017, 050758s017, 050759s022ltr.pdf
| 12/24/2008 |
AP | 0 | 12/15/2008 | SLR | 21467 | 019 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s19,050723s17,050758s17,050759s22lbl.pdf
| 1/2/2009 |
AP | 0 | 2/27/2009 | SLR | 21946 | 020 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,050758s018,050759s023ltr.pdf
| 3/5/2009 |
AP | 0 | 2/27/2009 | SLR | 22057 | 020 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s020,050723s018,050758s018,050759s023lbl.pdf
| 3/19/2009 |
AP | 0 | 6/18/2009 | SLR | 22807 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s021,050723s019,050758s019,050759s024ltr.pdf
| 6/23/2009 |
AP | 0 | 6/18/2009 | SLR | 22823 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf
| 6/24/2009 |
AP | 0 | 9/25/2012 | SLR | 33863 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf
| 9/27/2012 |
AP | 0 | 10/8/2009 | SLR | 23589 | 024 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s024,050723s023,050758s022,050759s028lbl.pdf
| 10/14/2009 |
AP | 0 | 10/8/2009 | SLR | 23759 | 024 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,050758s022,050759s028ltr.pdf
| 11/9/2009 |
AP | 0 | 6/8/2012 | SLR | 32900 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,050758s024,050759s031ltr.pdf
| 6/12/2012 |
AP | 0 | 6/8/2012 | SLR | 32941 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031lbl.pdf
| 6/18/2012 |
AP | 0 | 6/8/2012 | SLR | 32942 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031mg.pdf
| 6/18/2012 |
AP | 0 | 2/14/2013 | SCM | | | |
| |
AP | 0 | 6/22/2012 | SLR | 32995 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s028,050723s027,050758s026,050759s033ltr.pdf
| 6/26/2012 |
AP | 0 | 6/22/2012 | SLR | 33019 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033mg.pdf
| 6/26/2012 |
AP | 0 | 6/22/2012 | SLR | 33020 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033lbl.pdf
| 6/26/2012 |
AP | 0 | 9/27/2013 | SLR | 37284 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf
| 10/1/2013 |
AP | 0 | 9/27/2013 | SLR | 37308 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf
| 10/1/2013 |
AP | 0 | 9/27/2013 | SLR | 37285 | 031 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf
| 10/1/2013 |
AP | 0 | 9/27/2013 | SLR | 37309 | 031 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf
| 10/1/2013 |
AP | 0 | 1/23/2014 | SCM | | | |
| |
AP | 0 | 7/9/2015 | SLR | 43339 | 033 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050722s033,050723s032,050758s030,050759s038lbl.pdf
| 7/13/2015 |
AP | 0 | 7/9/2015 | SLR | 43356 | 033 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s033,050723Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf
| 7/14/2015 |
AP | 0 | 11/13/2015 | S | 44521 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf
| 11/19/2015 |