Action Type | Duplicate Counter | Action Date | Document Type | Application Document ID | Sequence Number | Document Title | Document URL | Document Date |
AP | 0 | 9/26/1997 | N | 16535 | 000 | |
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273
| 5/9/2007 |
AP | 0 | 9/26/1997 | N | 17294 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20639_seroquel_toc.cfm
| 7/17/2007 |
AP | 0 | 9/26/1997 | N | 24078 | 000 | |
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089126.pdf
| 11/20/2009 |
AP | 0 | 9/26/1997 | N | 31199 | 000 | Other Important Information from FDA |
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm
| 12/22/2011 |
AP | 0 | 2/23/1998 | SCM | | | |
| |
AP | 0 | 5/8/1998 | SCM | | | |
| |
AP | 0 | 12/20/1998 | SCM | | | |
| |
AP | 0 | 7/26/2000 | SCM | | | |
| |
AP | 0 | 7/7/2000 | SCM | | | |
| |
AP | 0 | 1/24/2001 | SCM | | | |
| |
AP | 0 | 11/6/2000 | SCM | | | |
| |
AP | 0 | 3/27/2001 | SLR | 1620 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20639S11LTR.PDF
| 3/27/2001 |
AP | 0 | 3/19/2001 | SCP | | | |
| |
AP | 0 | 11/16/2001 | SCM | | | |
| |
AP | 0 | 12/6/2002 | SCM | | | |
| |
AP | 0 | 1/12/2004 | SE1 | 7539 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20639se1-017,016ltr.pdf
| 1/14/2004 |
AP | 0 | 1/12/2004 | SE1 | 7551 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-017,016_seroquel_lbl.pdf
| 1/15/2004 |
AP | 0 | 1/12/2004 | SE1 | 18533 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020639_S016&S017_SEROQUEL TABLETS.pdf
| 11/19/2007 |
AP | 0 | 1/12/2004 | SE1 | 7540 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20639se1-017,016ltr.pdf
| 1/14/2004 |
AP | 0 | 1/12/2004 | SE1 | 7552 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639se1-017,016_seroquel_lbl.pdf
| 1/15/2004 |
AP | 0 | 1/12/2004 | SE1 | 18532 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020639_S016&S017_SEROQUEL TABLETS.pdf
| 11/19/2007 |
AP | 0 | 7/21/2004 | SLR | 9831 | 020 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20639s020ltr.pdf
| 7/21/2004 |
AP | 0 | 7/21/2004 | SLR | 9838 | 020 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20639s020lbl.pdf
| 7/21/2004 |
AP | 0 | 2/7/2006 | SCM | 13599 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020639s021ltr.pdf
| 2/8/2006 |
AP | 0 | 9/20/2006 | SLR | 14940 | 023 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s023lbl.pdf
| 9/21/2006 |
AP | 0 | 9/20/2006 | SLR | 14953 | 023 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020639s023ltr.pdf
| 9/25/2006 |
AP | 0 | 5/13/2008 | SLR | 19827 | 025 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf
| 5/14/2008 |
AP | 0 | 5/13/2008 | SLR | 19938 | 025 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf
| 6/5/2008 |
AP | 0 | 10/20/2006 | SE1 | 15144 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020639s026lbl.pdf
| 10/23/2006 |
AP | 0 | 10/20/2006 | SE1 | 15180 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020639s026ltr.pdf
| 10/23/2006 |
AP | 0 | 10/24/2008 | SCA | 21086 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s030ltr.pdf
| 10/28/2008 |
AP | 0 | 1/28/2008 | SLR | 18976 | 031 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s031ltr.pdf
| 1/30/2008 |
AP | 0 | 7/30/2007 | SLR | 17469 | 035 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020639s035ltr.pdf
| 8/2/2007 |
AP | 0 | 5/13/2008 | SE1 | 19828 | 037 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf
| 5/14/2008 |
AP | 0 | 5/13/2008 | SE1 | 19937 | 037 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf
| 6/5/2008 |
AP | 0 | 5/13/2008 | SE1 | 20221 | 037 | |
http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020639se1-037_SUMR.pdf
| 7/16/2008 |
AP | 0 | 5/13/2008 | SE1 | 30057 | 037 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020639s037.pdf
| 9/22/2011 |
AP | 0 | 5/13/2008 | SLR | 19829 | 038 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf
| 5/14/2008 |
AP | 0 | 5/13/2008 | SLR | 19936 | 038 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf
| 6/5/2008 |
AP | 0 | 1/28/2008 | SLR | 18977 | 039 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s039ltr.pdf
| 1/30/2008 |
AP | 0 | 5/13/2008 | SLR | 19830 | 040 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s025,se1-037,s038,s040ltr.pdf
| 5/14/2008 |
AP | 0 | 5/13/2008 | SLR | 19935 | 040 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020639s025s037s038s040lbl.pdf
| 6/5/2008 |
AP | 0 | 8/14/2008 | SLR | 20628 | 043 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020639s043ltr.pdf
| 8/19/2008 |
AP | 0 | 12/2/2009 | SE5 | 24271 | 045 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf
| 12/11/2009 |
AP | 0 | 12/2/2009 | SE5 | 24651 | 045 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020639s045s046ltr.pdf
| 1/27/2010 |
AP | 0 | 12/2/2009 | SE5 | 24272 | 046 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020639s045s046lbl.pdf
| 12/11/2009 |
AP | 0 | 12/2/2009 | SE5 | 24652 | 046 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020639s045s046ltr.pdf
| 1/27/2010 |
AP | 0 | 7/8/2011 | SLR | 29482 | 049 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s049,020639s054ltr.pdf
| 7/12/2011 |
AP | 0 | 7/8/2011 | SLR | 29491 | 049 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054lbl.pdf
| 7/12/2011 |
AP | 0 | 7/8/2011 | SLR | 29493 | 049 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054MedG.pdf
| 7/12/2011 |
AP | 0 | 7/8/2011 | SLR | 32058 | 049 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020639_seroquel_toc.cfm
| 3/7/2012 |
AP | 0 | 5/17/2011 | SLR | 28859 | 051 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s051ltr.pdf
| 5/19/2011 |
AP | 0 | 5/17/2011 | SLR | 28904 | 051 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s051lbl.pdf
| 5/23/2011 |
AP | 0 | 12/1/2010 | SLR | 27185 | 052 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020639s052lbl.pdf
| 12/4/2010 |
AP | 0 | 12/1/2010 | SLR | 27217 | 052 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020639s052ltr.pdf
| 12/6/2010 |
AP | 0 | 4/30/2013 | SLR | 35903 | 053 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf
| 5/1/2013 |
AP | 0 | 4/30/2013 | SLR | 35925 | 053 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf
| 5/2/2013 |
AP | 0 | 7/8/2011 | SLR | 29483 | 054 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s049,020639s054ltr.pdf
| 7/12/2011 |
AP | 0 | 7/8/2011 | SLR | 29492 | 054 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054lbl.pdf
| 7/12/2011 |
AP | 0 | 7/8/2011 | SLR | 29494 | 054 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s049s054MedG.pdf
| 7/12/2011 |
AP | 0 | 7/8/2011 | SLR | 32059 | 054 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020639_seroquel_toc.cfm
| 3/7/2012 |
AP | 0 | 11/9/2011 | SLR | 30554 | 055 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020639s055MG.pdf
| 11/10/2011 |
AP | 0 | 11/9/2011 | SLR | 30565 | 055 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020639s055ltr.pdf
| 11/14/2011 |
AP | 0 | 4/30/2013 | SE8 | 35904 | 057 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf
| 5/1/2013 |
AP | 0 | 4/30/2013 | SE8 | 35926 | 057 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf
| 5/2/2013 |
AP | 0 | 4/30/2013 | SLR | 35905 | 058 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf
| 5/1/2013 |
AP | 0 | 4/30/2013 | SLR | 35927 | 058 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf
| 5/2/2013 |
AP | 0 | 4/30/2013 | SLR | 35906 | 059 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s053s057s058s059lbl.pdf
| 5/1/2013 |
AP | 0 | 4/30/2013 | SLR | 35928 | 059 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf
| 5/2/2013 |
AP | 0 | 10/29/2013 | SLR | 37615 | 061 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s061,022047Orig1s034ltr.pdf
| 10/30/2013 |
AP | 0 | 10/29/2013 | SLR | 37645 | 061 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020639s061lbl.pdf
| 10/31/2013 |
AP | 0 | 6/17/2016 | SLR | 46360 | 064 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020639Orig1s064,022047Orig1s038ltr.pdf
| 6/21/2016 |
AP | 0 | 6/17/2016 | SLR | 46382 | 064 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020639s064lbl.pdf
| 6/21/2016 |