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FDA Drug Application 022360 by GLAXOSMITHKLINE CONS

Application Number022360
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE CONS
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
AP05/18/2009N22638000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022360s000ltr.pdf 5/27/2009
AP05/18/2009N24358000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022360_nicorette_toc.cfm 12/30/2009
AP05/18/2009N24359000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022360s000_SumR.pdf 12/30/2009
AP012/6/2011SLR30900002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022360s002ltr.pdf 12/8/2011
AP09/18/2012SLR33827004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022360Orig1s004ltr.pdf 9/24/2012
AP09/18/2012SLR35741004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022360Orig1s004lbl.pdf 4/17/2013
AP05/23/2013SLR36148006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022360Orig1s006ltr.pdf 5/28/2013
AP05/23/2013SLR37215006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s006lbl.pdf 9/24/2013
AP010/28/2013SLR37603007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022360Orig1s007ltr.pdf 10/29/2013
AP010/28/2013SLR37733007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022360Orig1s007lbl.pdf 11/7/2013
AP02/14/2014SCM44514008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022360Orig1s008.pdf 11/18/2015
AP04/16/2015SLR42553009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022360Orig1s009ltr.pdf 4/17/2015
AP04/16/2015SLR42597009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022360Orig1s009lbl.pdf 4/21/2015
AP09/30/2015SLR44096010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022360Orig1s010ltr.pdf 10/2/2015
AP09/30/2015SLR44250010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022360s010lbl.pdf 10/22/2015




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