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FDA Drug Application 020549 by GLAXOSMITHKLINE

Application Number020549
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/7/1997N4283000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020549ap.pdf 11/7/1997
AP012/3/1998SCS       
AP012/22/1998SLR1856002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20548-S008_Flovent.pdf 12/22/1998
AP01/19/2001SCS       
AP04/23/1999SCS       
AP07/19/1999SLR1195006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20549-S006_Flovent.pdf 7/19/1999
AP05/17/2000SCS       
AP03/29/2001SLR       
AP011/1/2000SCS       
AP08/27/2001SCS       
AP06/20/2003SLR6054012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20549slr012ltr.pdf 7/6/2003
AP06/20/2003SLR6074012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20549slr012_flovent_lbl.pdf 7/8/2003
AP010/8/2003SLR6790014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20549slr014ltr.pdf 10/16/2003
AP010/8/2003SLR6791014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20549slr014_flovent_lbl.pdf 10/16/2003
AP010/8/2003SLR9004014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20548-S008_Flovent.pdf 6/4/2004
AP03/26/2004SLR8252016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20549slr016,20548slr020,20121slr030_flonase_lbl.pdf 4/5/2004
AP03/26/2004SLR8306016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20549slr016,20548slr020,20121slr030ltr.pdf 4/7/2004




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