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FDA Drug Application 020983 by GLAXOSMITHKLINE

Application Number020983
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
AP04/19/2001N798000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20983ltr.pdf 4/19/2001
AP04/19/2001N799000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20983lbl.pdf 4/19/2001
AP04/19/2001N2263000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-983_Ventolin-HFA.cfm 4/19/2001
AP07/9/2001SCS       
AP010/25/2001SCM       
AP03/4/2002SCS       
AP09/10/2002SCM       
AP04/19/2005SCS11500009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020983s009ltr.pdf 4/28/2005
AP04/19/2005SCS11520009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020983s009lbl.pdf 4/28/2005
AP04/19/2005SCS31778009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020983Orig1s009Approv.pdf 2/14/2012
AP03/26/2008SE819540016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020983s016lbl.pdf 3/27/2008
AP03/26/2008SE819563016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020983s016ltr.pdf 4/2/2008
AP09/6/2012SLR33677027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020983Orig1s027ltr.pdf 9/7/2012
AP09/6/2012SLR33708027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020983s027lbl.pdf 9/11/2012
AP01/21/2014SCM       
AP01/3/2014SCM       
AP06/17/2014SCM       
AP012/19/2014SLR41371032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020983Orig1s032ltr.pdf 12/23/2014
AP012/19/2014SLR41582032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020983s032lbl.pdf 1/9/2015
AP01/12/2015SCM       
AP08/14/2015SCM       




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