Back to FDA Applications sponsored by GLAXOSMITHKLINE

FDA Drug Application 020066 by GLAXOSMITHKLINE

Application Number020066
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/8/1992N       
AP03/22/1993SCM       
AP03/22/1993SCM       
AP02/9/1996SE6       
AP011/4/1998SCS       
AP012/23/1998SE42957007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_Approv.pdf 12/13/1998
AP012/23/1998SE42958007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_prntlbl.pdf 12/23/1998
AP012/23/1998SE42959007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612s025_Nicorette.cfm 12/23/1998
AP08/24/2001SLR       
AP09/25/2000SCF2952010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-066S010_Nicorette_Approv.pdf 9/25/2000
AP09/25/2000SCF2953010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-066S010_Nicorette_prntlbl.pdf 9/25/2000
AP09/25/2000SCF2954010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-066s10_Nicorette.cfm 9/25/2000
AP08/9/2002SLR2956013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18612slr031,%2020066slr013ltr.pdf 8/9/2002
AP011/15/2002SCS       
AP04/23/2004SCF8439016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20066scf016ltr.pdf 4/29/2004
AP04/23/2004SCF16213016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020066_S016_NICORETTE_GUM_AP.pdf 4/11/2007
AP06/23/2004SLR9531017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20066slr017ltr.pdf 6/24/2004
AP06/18/2004SCF9500019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20066scf019ltr.pdf 6/23/2004
AP012/2/2005SCF13242023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018612s042,020066s023lbl.pdf 12/13/2005
AP012/2/2005SCF13248023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018612s042,020066s023ltr.pdf 12/13/2005
AP05/4/2006SCP14056024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018612s043,020066s024LTR.pdf 5/5/2006
AP06/26/2007SCF16852030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pdf 6/27/2007
AP06/26/2007SCF16892030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018612s049, 020066s030ltr.pdf 7/5/2007
AP06/13/2008SCF20020031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018612s050, 020066s031ltr.pdf 6/16/2008
AP06/13/2008SCF32210031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020066Orig1s031.pdf 3/27/2012
AP05/6/2009SE822471033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018612s052,020066s033ltr.pdf 5/8/2009
AP05/17/2011SLR28864037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018612s056,020066s037ltr.pdf 5/19/2011
AP09/27/2011SLR30139038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020066s038ltr.pdf 9/29/2011
AP02/1/2012SLR31652041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612s060,020066s041ltr.pdf 2/3/2012
AP02/15/2012SLR31810042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612s061,020066s042ltr.pdf 2/17/2012
AP02/15/2012SLR32261042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612s061_020066s042lbl.pdf 3/28/2012
AP07/16/2012SLR33222046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612Orig1s065,020066Orig1s046ltr.pdf 7/18/2012
AP07/16/2012SLR38299046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612Orig1s065, 020066Orig1s046lbl.pdf 1/16/2014
AP08/1/2012SCM       
AP010/30/2013SLR37630049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018612Orig1s068,020066Orig1s049ltr.pdf 10/31/2013
AP010/30/2013SLR37732049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018612Orig1s068,020066Orig1s049lbl.pdf 11/7/2013
AP04/17/2014SCM       
AP06/11/2014SLR39536053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s072,s073,020066Orig1s053,s054ltr.pdf 6/12/2014
AP06/11/2014SLR40139053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf 8/5/2014
AP06/11/2014SLR40140054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf 8/5/2014
AP06/11/2014SLR39537054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s072,s073,020066Orig1s053,s054ltr.pdf 6/12/2014
AP010/30/2014SLR40924055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s074,020066Orig1s055ltr.pdf 11/3/2014
AP010/30/2014SLR40967055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s074, 020066Orig1s055lbl.pdf 11/7/2014
AP09/30/2015SLR44083057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018612Orig1s076,020066Orig1s057ltr.pdf 10/2/2015
AP09/30/2015SLR44342057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020066s057lbl.pdf 11/2/2015




Back to FDA Applications sponsored by GLAXOSMITHKLINE

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.