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FDA Drug Application 021319 by GLAXOSMITHKLINE

Application Number021319
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
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
AP011/20/2001N4679000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen_approv.PDF 11/20/2001
AP011/20/2001N4680000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21319lbl.pdf 11/20/2001
AP011/20/2001N4681000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen.cfm 11/20/2001
AP011/20/2001N31030000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258424.htm 12/20/2011
AP010/9/2002SE14604001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21319se1-001ltr.pdf 10/9/2002
AP010/9/2002SE14605001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-319s1lbl.pdf 10/9/2002
AP010/9/2002SCP       
AP012/31/2002SCM       
AP03/12/2004SLR7994005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319slr005ltr.pdf 3/19/2004
AP08/5/2004SLR9947007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319s007ltr.pdf 8/6/2004
AP08/5/2004SLR9950007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s007lbl.pdf 8/6/2004
AP09/14/2004S10196008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21319s008ltr.pdf 9/15/2004
AP09/14/2004S10197008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s008lbl.pdf 9/15/2004
AP012/23/2005SLR13359009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021319s009rev2.pdf 1/6/2006
AP06/19/2008SE120053014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021319se1-014ltr.pdf 6/23/2008
AP06/19/2008SE120086014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s014lbl.pdf 6/26/2008
AP06/19/2008SE120228014   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021319se1-014_SUMR.pdf 7/17/2008
AP03/31/2008SLR19555015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s015lbl.pdf 4/1/2008
AP03/31/2008SLR19564015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021319s015ltr.pdf 4/2/2008
AP06/15/2010SLR25758018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021319s018ltr.pdf 6/18/2010
AP06/15/2010SLR25785018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s018lbl.pdf 6/24/2010
AP09/9/2010SLR26444022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021319s022lbl.pdf 9/10/2010
AP09/9/2010SLR26474022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021319s022ltr.pdf 9/13/2010
AP06/9/2011SE129099023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf 6/10/2011
AP06/9/2011SE129101023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021319s023,s025ltr.pdf 6/10/2011
AP06/9/2011SLR29102025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021319s023,s025ltr.pdf 6/10/2011
AP06/9/2011SLR29100025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf 6/10/2011
AP06/27/2012SLR33050027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021319s027lbl.pdf 6/28/2012
AP06/27/2012SLR33054027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021319s027ltr.pdf 6/29/2012
AP04/30/2013SLR35901028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf 5/1/2013
AP04/30/2013SLR35933028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021319Orig1s028,s029ltr.pdf 5/2/2013
AP04/30/2013SLR35934029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021319Orig1s028,s029ltr.pdf 5/2/2013
AP04/30/2013SLR35902029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf 5/1/2013
AP09/10/2013SCM       




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