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FDA Drug Application 020825 by PFIZER

Application Number020825
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/5/2001N324000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20825ltr.pdf 2/5/2001
AP02/5/2001N325000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20825lbl.pdf 2/5/2001
AP02/5/2001N2121000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-825_Geodan.cfm 2/5/2001
AP02/5/2001N31200000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP06/7/2001SCP       
AP05/25/2001SCP       
AP05/25/2001SCM       
AP01/22/2002SCE       
AP06/25/2002SCM       
AP02/15/2002SLR2116006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20825s6ltr.pdf 2/15/2002
AP012/23/2003SLR7418008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20825slr008,20919slr001ltr.pdf 12/24/2003
AP08/19/2004SE110322009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s009rev2.pdf 10/1/2004
AP08/19/2004SE110323009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020825s009lbl.pdf 10/1/2004
AP08/19/2004SE110324009Corrected Approval Letter  http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s009ltr.pdf 10/1/2004
AP08/13/2004SLR10047012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20825s012,20919s003ltr.pdf 8/25/2004
AP08/17/2005SLR12625015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020825s015,017,020919s005,006ltr.pdf 8/19/2005
AP08/17/2005SLR12644015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf 8/19/2005
AP08/17/2005SLR12626017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020825s015,017,020919s005,006ltr.pdf 8/19/2005
AP08/17/2005SLR12645017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf 8/19/2005
AP03/2/2007SLR15972021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s021, 020919s012ltr.pdf 3/7/2007
AP03/2/2007SLR15990021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s021,020919s012lbl.pdf 3/7/2007
AP03/2/2007SLR20329021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020825_s021_GEODON.pdf 7/30/2008
AP05/24/2007SLR16593024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s024,020919s014ltr.pdf 5/29/2007
AP05/24/2007SLR16634024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s024,020919s014lbl.pdf 5/29/2007
AP010/2/2007SLR18123026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020825s026, 020919s016ltr.pdf 10/4/2007
AP010/2/2007SLR18162026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s026,020919s016lbl.pdf 10/4/2007
AP05/16/2008SLR19853027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020825s027,020919s019ltr.pdf 5/21/2008
AP011/12/2009SLR       
AP08/14/2008SLR20636030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020825s030, 020919s021ltr.pdf 8/19/2008
AP011/20/2009SE124104034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020825s034lbl.pdf 11/23/2009
AP011/20/2009SE124120034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020825s034ltr.pdf 11/24/2009
AP011/20/2009SE134051034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020825Orig1s034.pdf 10/12/2012
AP07/19/2009SLR23122035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020825s035,020919s023ltr.pdf 8/4/2009
AP07/19/2009SLR23195035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020825s035,020919s023lbl.pdf 8/14/2009
AP012/1/2010SLR27164038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020825s038,020919s025,021483s005lbl.pdf 12/4/2010
AP012/1/2010SLR27233038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020825s038,020919s025,021483s005ltr.pdf 12/7/2010
AP07/3/2013SLR36457041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s041,020919Orig1s027,021483Orig1s007ltr.pdf 7/5/2013
AP07/3/2013SLR36469041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s041,020919s027,021483s007lbl.pdf 7/5/2013
AP03/1/2013SLR35334046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s046,020919s030,021483s009lbl.pdf 3/4/2013
AP03/1/2013SLR35344046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Origs046,020919Orig1s030,021483Orig1s009ltr.pdf 3/5/2013
AP08/13/2013SLR36804047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s047,020919s032,021483s010lbl.pdf 8/15/2013
AP08/13/2013SLR36808047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s047,020919Orig1s032,021483Orig1s010ltr.pdf 8/16/2013
AP012/17/2013SLR38107049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s049,020919s035lbl.pdf 12/19/2013
AP012/17/2013SLR38109049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s049,020919Orig1s035ltr.pdf 12/19/2013
AP06/17/2015SCM       
AP012/10/2014SLR41214053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020825Orig1s053,020919Orig1s040,021483Orig1s013ltr.pdf 12/11/2014
AP012/10/2014SLR41220053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020825s053,020919s040,s021483s013lbl.pdf 12/11/2014
AP08/20/2015SLR43698054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020825Orig1s054,020919Orig1s041,021483Orig1s014ltr.pdf 8/24/2015
AP08/20/2015SLR43862054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020825s054,020919s041,021483s014lbl.pdf 9/14/2015




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