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FDA Drug Application 020500 by GLAXOSMITHKLINE LLC

Application Number020500
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/8/1995N       
AP04/28/1995SCS       
AP05/2/1997SLR       
AP08/12/1997SCM       
AP09/14/1998SCP       
AP01/5/1999SE19202005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20500s5ltr.pdf 6/9/2004
AP01/5/1999SE19203005   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20-500-S005.PDF 6/9/2004
AP01/5/1999SE19204005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020500S005.cfm 6/9/2004
AP05/7/2008SLR19795010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020500s010ltr.pdf 5/9/2008
AP05/7/2008SLR19803010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020500s010lbl.pdf 5/12/2008
AP03/1/2013SLR35326014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020500Orig1s014ltr.pdf 3/4/2013
AP03/1/2013SLR35342014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020500s014lbl.pdf 3/5/2013
AP06/4/2015SLR43012015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020500Orig1s015ltr.pdf 6/10/2015
AP06/4/2015SLR43024015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020500s015lbl.pdf 6/10/2015




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