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FDA Drug Application 021433 by GLAXO GRP LTD

Application Number021433
Application Type New Drug Application
Sponsor ApplicantGLAXO GRP LTD
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
AP05/14/2004N8639000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21433ltr.pdf 5/26/2004
AP05/14/2004N8715000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21433_flovent_lbl.pdf 5/27/2004
AP05/14/2004N13225000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021433s000_FloventHFATOC.cfm 12/6/2005
AP02/28/2006SE513710004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021433s004lbl.pdf 3/3/2006
AP02/28/2006SE513722004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021433s004ltr.pdf 3/3/2006
AP012/21/2005SLR13324005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021433s005lbl.pdf 1/5/2006
AP012/21/2005SLR13398005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021433s005rev2.pdf 1/18/2006
AP010/25/2006SCS15244006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021433s006lbl.pdf 10/26/2006
AP010/25/2006SCS15277006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021433s006ltr.pdf 10/27/2006
AP07/1/2008SLR20153011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021433s011ltr.pdf 7/2/2008
AP07/1/2008SLR20173011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021433s011lbl.pdf 7/9/2008
AP011/3/2010SLR26895015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021433s015lbl.pdf 11/3/2010
AP011/3/2010SLR26898015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021433s015ltr.pdf 11/8/2010
AP07/28/2011SLR29706019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021433s019lbl.pdf 8/5/2011
AP07/28/2011SLR41128019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021433s019ltr.pdf 12/3/2014
AP06/19/2013SCM       
AP07/18/2013SCM36578022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021433Orig1s022ltr.pdf 7/22/2013
AP07/18/2013SCM36591022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021433s022lbl.pdf 7/23/2013
AP06/17/2014SCM       
AP06/17/2014SCM       
AP011/14/2014SLR41002025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021433Orig1s025ltr.pdf 11/17/2014
AP011/14/2014SLR41048025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021433s025lbl.pdf 11/20/2014
AP012/10/2014SLR41225026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021433s026lbl.pdf 12/11/2014
AP012/10/2014SLR41229026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021433Orig1s026ltr.pdf 12/12/2014
AP01/6/2016SCM       
AP05/20/2016SCM       
AP07/28/2016SLR46687031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021433Orig1s031ltr.pdf 8/1/2016
AP07/28/2016SLR46705031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s031lbl.pdf 8/2/2016
AP010/5/2016SLR47297032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021433Orig1s032ltr.pdf 10/6/2016
AP010/5/2016SLR47307032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021433s032lbl.pdf 10/7/2016




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