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FDA Drug Application 205434 by GLAXOSMITHKLINE CONS

Application Number205434
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE CONS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type OTC (over-the-counter) switch
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/23/2014N39997000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205434Orig1s000ltr.pdf 7/25/2014
AP07/23/2014N39998000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205434Orig1s000lbl.pdf 7/25/2014
AP07/23/2014N45459000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205434Orig1s000TOC.cfm 3/18/2016
AP09/30/2015SLR44080001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205434Orig1s001ltr.pdf 10/2/2015
AP09/30/2015SLR44206001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205434Orig1s001lbledt.pdf 10/15/2015
AP09/22/2015SCM       
AP011/25/2015SLR44610003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205434Orig1s003ltr.pdf 11/27/2015
AP011/25/2015SLR44714003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205434s003lbl.pdf 12/9/2015




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