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FDA Drug Application 020297 by SMITHKLINE BEECHAM

Application Number020297
Application Type New Drug Application
Sponsor ApplicantSMITHKLINE BEECHAM
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
AP09/14/1995N       
AP05/29/1997SE1       
AP05/20/1996SCS       
AP07/28/1998SLR       
AP09/8/1999SLR1295004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20297s4_Coreg.pdf 9/8/1999
AP010/25/2000SCP       
AP07/10/2001SCM       
AP011/1/2001SE12581007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg_Approv.pdf 11/1/2001
AP011/1/2001SE12582007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg_prntlbl.pdf 11/1/2001
AP011/1/2001SE12583007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-297S007_Coreg.cfm 11/1/2001
AP011/8/2002SCS       
AP03/27/2003SE14668009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20297se1-009ltr.pdf 3/28/2003
AP03/27/2003SE16104009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-297s009_Coreg.cfm 7/8/2003
AP09/29/2003SLR6723011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20297slr011ltr.pdf 9/30/2003
AP04/29/2005SE111550013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020297s013ltr.pdf 5/2/2005
AP04/29/2005SE111557013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020297s013lbl.pdf 5/2/2005
AP08/17/2005SLR12622017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020297s017ltr.pdf 8/19/2005
AP08/28/2006SE814768018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020297s018lbl.pdf 8/29/2006
AP08/28/2006SE814872018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s018ltr.pdf 9/18/2006
AP09/5/2006SLR14800020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020297s020pi.pdf 9/12/2006
AP09/5/2006SLR14845020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s020_ltr.pdf 9/18/2006
AP012/20/2006SLR15523021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020297s021ltr.pdf 12/28/2006
AP02/23/2007SE515912022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020297s022lbl.pdf 2/26/2007
AP02/23/2007SE515953022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020297s022ltr.pdf 3/6/2007
AP07/21/2008SLR20274028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020297s028ltr.pdf 7/23/2008
AP07/21/2008SLR20280028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s028lbl.pdf 7/23/2008
AP06/23/2009SLR22829029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020297s029ltr.pdf 6/26/2009
AP06/23/2009SLR22838029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020297s029lbl.pdf 6/29/2009
AP012/19/2008SLR21409030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020297s030ltr.pdf 12/24/2008
AP012/19/2008SLR21504030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020297s030lbl.pdf 1/6/2009
AP01/25/2011SLR27638033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s033lbl.pdf 1/31/2011
AP01/25/2011SLR27668033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s033,022012s016ltr.pdf 2/2/2011
AP01/6/2011SLR27489034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s034,s035ltr.pdf 1/7/2011
AP01/6/2011SLR27498034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf 1/10/2011
AP01/6/2011SLR27490035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s034,s035ltr.pdf 1/7/2011
AP01/6/2011SLR27499035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s034s035lbl.pdf 1/10/2011
AP07/6/2011SLR29446036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s036,022012s020ltr.pdf 7/7/2011
AP07/6/2011SLR29486036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020297s036lbl.pdf 7/12/2011
AP010/2/2015SLR44113037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020297Orig1s037ltr.pdf 10/6/2015
AP010/2/2015SLR44172037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020297s037lbl.pdf 10/8/2015




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