Action Type | Duplicate Counter | Action Date | Document Type | Application Document ID | Sequence Number | Document Title | Document URL | Document Date |
AP | 0 | 2/5/2001 | N | 324 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20825ltr.pdf
| 2/5/2001 |
AP | 0 | 2/5/2001 | N | 325 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20825lbl.pdf
| 2/5/2001 |
AP | 0 | 2/5/2001 | N | 2121 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-825_Geodan.cfm
| 2/5/2001 |
AP | 0 | 2/5/2001 | N | 31200 | 000 | |
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm
| 12/22/2011 |
AP | 0 | 6/7/2001 | SCP | | | |
| |
AP | 0 | 5/25/2001 | SCP | | | |
| |
AP | 0 | 5/25/2001 | SCM | | | |
| |
AP | 0 | 1/22/2002 | SCE | | | |
| |
AP | 0 | 6/25/2002 | SCM | | | |
| |
AP | 0 | 2/15/2002 | SLR | 2116 | 006 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20825s6ltr.pdf
| 2/15/2002 |
AP | 0 | 12/23/2003 | SLR | 7418 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20825slr008,20919slr001ltr.pdf
| 12/24/2003 |
AP | 0 | 8/19/2004 | SE1 | 10322 | 009 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s009rev2.pdf
| 10/1/2004 |
AP | 0 | 8/19/2004 | SE1 | 10323 | 009 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020825s009lbl.pdf
| 10/1/2004 |
AP | 0 | 8/19/2004 | SE1 | 10324 | 009 | Corrected Approval Letter |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s009ltr.pdf
| 10/1/2004 |
AP | 0 | 8/13/2004 | SLR | 10047 | 012 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s012,20919s003ltr.pdf
| 8/25/2004 |
AP | 0 | 8/17/2005 | SLR | 12625 | 015 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020825s015,017,020919s005,006ltr.pdf
| 8/19/2005 |
AP | 0 | 8/17/2005 | SLR | 12644 | 015 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf
| 8/19/2005 |
AP | 0 | 8/17/2005 | SLR | 12626 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020825s015,017,020919s005,006ltr.pdf
| 8/19/2005 |
AP | 0 | 8/17/2005 | SLR | 12645 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf
| 8/19/2005 |
AP | 0 | 3/2/2007 | SLR | 15972 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s021, 020919s012ltr.pdf
| 3/7/2007 |
AP | 0 | 3/2/2007 | SLR | 15990 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s021,020919s012lbl.pdf
| 3/7/2007 |
AP | 0 | 3/2/2007 | SLR | 20329 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020825_s021_GEODON.pdf
| 7/30/2008 |
AP | 0 | 5/24/2007 | SLR | 16593 | 024 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s024,020919s014ltr.pdf
| 5/29/2007 |
AP | 0 | 5/24/2007 | SLR | 16634 | 024 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s024,020919s014lbl.pdf
| 5/29/2007 |
AP | 0 | 10/2/2007 | SLR | 18123 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s026, 020919s016ltr.pdf
| 10/4/2007 |
AP | 0 | 10/2/2007 | SLR | 18162 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s026,020919s016lbl.pdf
| 10/4/2007 |
AP | 0 | 5/16/2008 | SLR | 19853 | 027 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020825s027,020919s019ltr.pdf
| 5/21/2008 |
AP | 0 | 11/12/2009 | SLR | | | |
| |
AP | 0 | 8/14/2008 | SLR | 20636 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020825s030, 020919s021ltr.pdf
| 8/19/2008 |
AP | 0 | 11/20/2009 | SE1 | 24104 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020825s034lbl.pdf
| 11/23/2009 |
AP | 0 | 11/20/2009 | SE1 | 24120 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020825s034ltr.pdf
| 11/24/2009 |
AP | 0 | 11/20/2009 | SE1 | 34051 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020825Orig1s034.pdf
| 10/12/2012 |
AP | 0 | 7/19/2009 | SLR | 23122 | 035 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020825s035,020919s023ltr.pdf
| 8/4/2009 |
AP | 0 | 7/19/2009 | SLR | 23195 | 035 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020825s035,020919s023lbl.pdf
| 8/14/2009 |
AP | 0 | 12/1/2010 | SLR | 27164 | 038 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020825s038,020919s025,021483s005lbl.pdf
| 12/4/2010 |
AP | 0 | 12/1/2010 | SLR | 27233 | 038 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020825s038,020919s025,021483s005ltr.pdf
| 12/7/2010 |
AP | 0 | 7/3/2013 | SLR | 36457 | 041 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s041,020919Orig1s027,021483Orig1s007ltr.pdf
| 7/5/2013 |
AP | 0 | 7/3/2013 | SLR | 36469 | 041 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s041,020919s027,021483s007lbl.pdf
| 7/5/2013 |
AP | 0 | 3/1/2013 | SLR | 35334 | 046 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s046,020919s030,021483s009lbl.pdf
| 3/4/2013 |
AP | 0 | 3/1/2013 | SLR | 35344 | 046 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Origs046,020919Orig1s030,021483Orig1s009ltr.pdf
| 3/5/2013 |
AP | 0 | 8/13/2013 | SLR | 36804 | 047 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s047,020919s032,021483s010lbl.pdf
| 8/15/2013 |
AP | 0 | 8/13/2013 | SLR | 36808 | 047 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s047,020919Orig1s032,021483Orig1s010ltr.pdf
| 8/16/2013 |
AP | 0 | 12/17/2013 | SLR | 38107 | 049 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s049,020919s035lbl.pdf
| 12/19/2013 |
AP | 0 | 12/17/2013 | SLR | 38109 | 049 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s049,020919Orig1s035ltr.pdf
| 12/19/2013 |
AP | 0 | 6/17/2015 | SCM | | | |
| |
AP | 0 | 12/10/2014 | SLR | 41214 | 053 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020825Orig1s053,020919Orig1s040,021483Orig1s013ltr.pdf
| 12/11/2014 |
AP | 0 | 12/10/2014 | SLR | 41220 | 053 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020825s053,020919s040,s021483s013lbl.pdf
| 12/11/2014 |
AP | 0 | 8/20/2015 | SLR | 43698 | 054 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020825Orig1s054,020919Orig1s041,021483Orig1s014ltr.pdf
| 8/24/2015 |
AP | 0 | 8/20/2015 | SLR | 43862 | 054 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020825s054,020919s041,021483s014lbl.pdf
| 9/14/2015 |