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FDA Drug Application 020121 by GLAXOSMITHKLINE

Application Number020121
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
AP010/19/1994N       
AP08/1/1995SCS       
AP03/27/1996SLR       
AP012/12/1996SLR       
AP010/31/1997SE125611005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20121.pdf 5/25/2010
AP02/18/1998SCS       
AP09/26/2000SCS       
AP012/11/1998SE1705009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20121s9ltr.pdf 12/11/1998
AP012/11/1998SE11855009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20121S009_Flonase.cfm 12/11/1998
AP012/11/1998SE14719009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20121-S009_FLONASE_prntlbl.pdf 12/11/1998
AP010/1/1998SLR       
AP05/9/2002SLR1852011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/NDA20121S011.pdf 5/9/2002
AP02/18/2000SCM       
AP05/9/2002SLR1853013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/NDA20121S011.pdf 5/9/2002
AP05/17/2000SCS       
AP06/20/2000SCM       
AP08/3/2001SCS       
AP05/9/2002SLR1854020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/NDA20121S011.pdf 5/9/2002
AP06/25/2001SCS       
AP07/9/2001SCS       
AP05/23/2002SE21851023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20121s023ltr.pdf 5/23/2002
AP02/19/2002SCS       
AP03/4/2002SCS       
AP05/7/2002SCP       
AP05/1/2003SE85583028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020121s028lbl.pdf 5/6/2003
AP05/1/2003SE85751028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20121se8-028ltr.pdf 5/30/2003
AP03/26/2004SLR8254030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20549slr016,20548slr020,20121slr030_flonase_lbl.pdf 4/5/2004
AP03/26/2004SLR8308030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20549slr016,20548slr020,20121slr030ltr.pdf 4/7/2004
AP06/19/2013SCM       
AP06/17/2014SCM       
AP06/17/2014SCM       
AP01/23/2015SLR41676044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020121Orig1s044ltr.pdf 1/26/2015
AP01/23/2015SLR41738044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020121s044lbl.pdf 1/30/2015




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