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FDA Drug Application 019151 by GLAXOSMITHKLINE LLC

Application Number019151
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
AP011/27/1989N       
AP011/20/1992SCS       
AP012/23/1997SE14342002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19151.pdf 12/23/1997
AP011/23/1993SCM       
AP03/19/1997SLR       
AP012/5/2002SLR3222005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19151slr005slr009ltr.pdf 12/5/2002
AP09/24/1999SCM       
AP07/14/2000SCM       
AP012/21/2000SCS       
AP012/5/2002SLR9394009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19151slr005slr009ltr.pdf 6/16/2004
AP01/11/2002SCS       
AP03/20/2013SLR35496012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019151Orig1s012ltr.pdf 3/22/2013
AP03/20/2013SLR35538012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019151s012lbl.pdf 3/26/2013
AP07/11/2014SCM       




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