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FDA Drug Application 020998 by GD SEARLE

Application Number020998
Application Type New Drug Application
Sponsor ApplicantGD SEARLE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/31/1998N845000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20998ltr.pdf 12/31/1998
AP012/31/1998N846000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20998.cfm 12/31/1998
AP012/31/1998N847000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20998lbl.pdf 12/31/1998
AP012/31/1998N7100000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm 12/9/2003
AP012/31/1998N23893000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088567.pdf 11/16/2009
AP08/13/1999SCP17306001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020998_S001_CELEBREX.pdf 7/18/2007
AP02/17/2000SCM17305004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020998_S004_CELEBREX.pdf 7/18/2007
AP03/21/2000SCM17303006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020998_S006_CELEBREX.pdf 7/18/2007
AP012/23/1999SLR8812007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21156-S007_Celebrex.cfm 5/28/2004
AP012/23/1999SLR8813007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21156ltr.pdf 5/28/2004
AP012/23/1999SLR8814007   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21156lbl.pdf 5/28/2004
AP012/1/2000SLR17304008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020998_S008_CELEBREX.pdf 7/18/2007
AP06/7/2002SE82349009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20998s009ltr.pdf 6/7/2002
AP06/7/2002SE82350009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20998s009lbl.pdf 6/7/2002
AP06/7/2002SE82351009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-998s009_Celebrex.cfm 6/7/2002
AP010/18/2001SE12347010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20998s10ltr.pdf 10/18/2001
AP010/18/2001SE12348010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20998s10lbl.pdf 10/18/2001
AP010/18/2001SE111066010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-998s010_Celebrex.cfm 2/2/2005
AP07/30/2001SCS       
AP08/15/2001SCS       
AP08/29/2002SCS11093013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-998s013_Celebrex.cfm 2/8/2005
AP08/29/2002SCS2346013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20998scs013ltr.pdf 8/29/2002
AP09/16/2002SCP22835014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020998_S014_CELEBREXTOC.cfm 6/29/2009
AP01/9/2004SLR7542016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20998slr016ltr.pdf 1/14/2004
AP01/9/2004SLR7557016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20998slr016_celebrex_lbl.pdf 1/15/2004
AP01/9/2004SLR14191016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020998_s016_CelebrexTOC.cfm 5/30/2006
AP02/9/2005SLR11116017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s017lbl.pdf 2/17/2005
AP02/9/2005SLR11117017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20998s017ltr.pdf 2/17/2005
AP07/29/2005SE112501018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020998s018,019ltr.pdf 8/3/2005
AP07/29/2005SE112512018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s018,019lbl.pdf 8/3/2005
AP07/29/2005SLR12513019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020998s018,019lbl.pdf 8/3/2005
AP07/29/2005SLR12502019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020998s018,019ltr.pdf 8/3/2005
AP012/15/2006SE515493021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020998s021lbl.pdf 12/26/2006
AP012/15/2006SE515545021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020998s021ltr.pdf 12/28/2006
AP06/1/2007SLR16683022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020998s022lbl.pdf 6/4/2007
AP06/1/2007SLR16718022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020998s022ltr.pdf 6/7/2007
AP011/2/2007SLR18359023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020998s023ltr.pdf 11/8/2007
AP01/14/2008SLR18895026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020998s026lbl.pdf 1/18/2008
AP01/14/2008SLR18900026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020998s026ltr.pdf 1/18/2008
AP012/31/2008SE221534027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020998s027lbl.pdf 1/6/2009
AP012/31/2008SE221547027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020998s027ltr.pdf 1/6/2009
AP02/4/2011SLR27770033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003lbl.pdf 2/9/2011
AP02/4/2011SLR27771033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003MedG.pdf 2/9/2011
AP02/4/2011SLR27791033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020998s033,021156s003ltr.pdf 2/9/2011
AP011/16/2012SCM       
AP07/29/2013SCM       
AP07/28/2014SCM       
AP05/9/2016SLR45919047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020998Orig1s047,s048ltr.pdf 5/11/2016
AP05/9/2016SLR45920048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020998Orig1s047,s048ltr.pdf 5/11/2016
AP05/9/2016SLR45939048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020998s048lbl.pdf 5/11/2016




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