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FDA Drug Application 020548 by GLAXOSMITHKLINE

Application Number020548
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
AP03/27/1996N       
AP05/7/1996SCS       
AP06/5/1996SCS       
AP010/14/1997SLR       
AP02/18/1998SCS       
AP04/13/1998SCM       
AP07/31/1998SCS       
AP011/4/1998SCS       
AP012/22/1998SLR1099008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20548-S008_Flovent.pdf 12/22/1998
AP05/17/2000SCS       
AP08/15/2001SCM       
AP06/20/2003SLR6053016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20548slr016,015ltr.pdf 7/6/2003
AP06/20/2003SLR6075016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr016_flovent_lbl.pdf 7/8/2003
AP010/8/2003SLR6792019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20548slr019LTR.pdf 10/16/2003
AP010/8/2003SLR6793019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr019_flovent_lbl.pdf 10/16/2003
AP03/26/2004SLR8253020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20548slr020,20121slr030_flovent_lbl.pdf 4/5/2004
AP03/26/2004SLR8307020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20549slr016,20548slr020,20121slr030ltr.pdf 4/7/2004




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