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FDA Drug Application 020763 by GLAXOSMITHKLINE LLC

Application Number020763
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/10/1998N7082000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm 12/8/2003
AP02/10/1998N8713000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20763_Amerge.cfm 5/27/2004
AP02/10/1998N208000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20763ltr.pdf 2/10/1998
AP02/10/1998N209000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20763lbl.pdf 2/10/1998
AP010/16/2013SLR37454001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020763Orig1s001,s002,s010ltr.pdf 10/18/2013
AP010/16/2013SLR37465001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020763s001s002s010lbl.pdf 10/18/2013
AP010/16/2013SLR37466002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020763s001s002s010lbl.pdf 10/18/2013
AP010/16/2013SLR37455002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020763Orig1s001,s002,s010ltr.pdf 10/18/2013
AP07/21/2000SCS       
AP09/7/2001SCM       
AP010/27/2003SLR6876005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20763slr005ltr.pdf 11/5/2003
AP08/11/2010SLR26212006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020763s006ltr.pdf 8/16/2010
AP08/11/2010SLR26256006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020763s006lbl.pdf 8/19/2010
AP03/1/2012SLR32004008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020763s008,s009ltr.pdf 3/5/2012
AP03/1/2012SLR32040008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020763s008s009lbl.pdf 3/6/2012
AP03/1/2012SLR32041009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020763s008s009lbl.pdf 3/6/2012
AP03/1/2012SLR32005009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020763s008,s009ltr.pdf 3/5/2012
AP010/16/2013SLR37456010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020763Orig1s001,s002,s010ltr.pdf 10/18/2013
AP010/16/2013SLR37467010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020763s001s002s010lbl.pdf 10/18/2013




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