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FDA Drug Application 018612 by GLAXOSMITHKLINE

Application Number018612
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/13/1984N       
AP02/21/1984SLR       
AP03/2/1984SLR       
AP09/12/1988SLR       
AP02/26/1986SCM       
AP07/23/1985SCP       
AP02/26/1986SCS       
AP09/12/1988SLR       
AP07/23/1985SLR       
AP04/17/1989SCM       
AP09/28/1989SCM       
AP09/30/1988SCS       
AP08/22/1991SCS       
AP08/22/1991SCS       
AP02/9/1996SE611562022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018612s022_020066s004_Nicorette.cfm 5/2/2005
AP011/4/1998SCS       
AP012/23/1998SE42960025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_Approv.pdf 12/23/1998
AP012/23/1998SE42961025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_prntlbl.pdf 12/23/1998
AP012/23/1998SE42962025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612s025_Nicorette.cfm 12/23/1998
AP08/24/2001SLR       
AP09/25/2000SCF       
AP08/9/2002SLR2955031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18612slr031,%2020066slr013ltr.pdf 8/9/2002
AP011/15/2002SCS       
AP04/23/2004SCF8435034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18612scf034ltr.pdf 4/29/2004
AP04/23/2004SCF17118034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018612_S034_NICORETTE_GUM_AP.pdf 7/6/2007
AP06/23/2004SLR9532035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18612slr035ltr.pdf 6/24/2004
AP06/18/2004SCF9501037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18612scf037ltr.pdf 6/23/2004
AP012/2/2005SCF13241042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018612s042,020066s023lbl.pdf 12/13/2005
AP012/2/2005SCF13249042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018612s042,020066s023ltr.pdf 12/13/2005
AP05/4/2006SCP14057043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018612s043,020066s024LTR.pdf 5/5/2006
AP06/26/2007SLR16851049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pdf 6/27/2007
AP06/26/2007SLR16893049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018612s049, 020066s030ltr.pdf 7/5/2007
AP06/13/2008SCF20019050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018612s050, 020066s031ltr.pdf 6/16/2008
AP06/13/2008SCF32204050   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/018612Orig1s050.pdf 3/27/2012
AP05/6/2009SE822470052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018612s052,020066s033ltr.pdf 5/8/2009
AP05/17/2011SLR28863056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018612s056,020066s037ltr.pdf 5/19/2011
AP09/27/2011SLR30140057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018612s057ltr.pdf 9/29/2011
AP09/12/2011SCM       
AP02/1/2012SLR31651060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612s060,020066s041ltr.pdf 2/3/2012
AP02/15/2012SLR31809061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612s061,020066s042ltr.pdf 2/17/2012
AP02/15/2012SLR32260061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612s061_020066s042lbl.pdf 3/28/2012
AP07/16/2012SLR33221065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612Orig1s065,020066Orig1s046ltr.pdf 7/18/2012
AP07/16/2012SLR38300065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612Orig1s065, 020066Orig1s046lbl.pdf 1/16/2014
AP08/1/2012SCM       
AP010/30/2013SLR37629068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018612Orig1s068,020066Orig1s049ltr.pdf 10/31/2013
AP010/30/2013SLR37731068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018612Orig1s068,020066Orig1s049lbl.pdf 11/7/2013
AP010/11/2013SCM       
AP04/17/2014SCM       
AP02/21/2014SCM       
AP06/11/2014SLR39534072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s072,s073,020066Orig1s053,s054ltr.pdf 6/12/2014
AP06/11/2014SLR40141072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf 8/5/2014
AP06/11/2014SLR40142073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf 8/5/2014
AP06/11/2014SLR39535073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s072,s073,020066Orig1s053,s054ltr.pdf 6/12/2014
AP010/30/2014SLR40923074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s074,020066Orig1s055ltr.pdf 11/3/2014
AP010/30/2014SLR40968074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s074, 020066Orig1s055lbl.pdf 11/7/2014
AP01/5/2015SCM       
AP09/30/2015SLR44082076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018612Orig1s076,020066Orig1s057ltr.pdf 10/2/2015
AP09/30/2015SLR44343076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018612s076lbl.pdf 11/2/2015
AP09/10/2015SCM       




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