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FDA Drug Application 020080 by GLAXOSMITHKLINE

Application Number020080
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/28/1992N15675000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm 1/17/2007
AP09/30/1993SCM       
AP08/17/1994SLR       
AP05/22/1996SE1       
AP012/23/1996SCP3739005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020080ap.pdf 11/20/1997
AP06/7/1995SCM       
AP010/5/1995SCS       
AP011/29/1995SCM       
AP03/28/1996SCM       
AP02/2/2001SLR       
AP012/16/1997SCM       
AP011/26/1997SCS       
AP02/2/2001SLR       
AP02/2/2001SLR       
AP02/2/2001SLR       
AP02/2/2001SLR       
AP01/3/2003SLR9100029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20080slr029ltr.pdf 6/7/2004
AP07/28/2003SLR6509030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20132slr014,20626slr007,20080slr030ltr.pdf 8/15/2003
AP07/28/2003SLR17372030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020080_S030_IMITREX TABLETS, NASAL SPRAY INJ.pdf 7/24/2007
AP02/1/2006SE213588036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020080s036lbl.pdf 2/7/2006
AP02/1/2006SE213614036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020080s036ltr.pdf 2/8/2006
AP07/21/2010SLR26024038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020080s038ltr.pdf 7/28/2010
AP07/21/2010SLR26058038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020080s038lbl.pdf 7/31/2010
AP010/2/2012SLR33955039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020080Orig1s039,040,041,045ltr.pdf 10/4/2012
AP010/2/2012SLR33971039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf 10/4/2012
AP010/2/2012SLR33972040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf 10/4/2012
AP010/2/2012SLR33956040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020080Orig1s039,040,041,045ltr.pdf 10/4/2012
AP010/2/2012SLR33957041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020080Orig1s039,040,041,045ltr.pdf 10/4/2012
AP010/2/2012SLR33973041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf 10/4/2012
AP010/2/2012SLR33974045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf 10/4/2012
AP010/2/2012SLR33958045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020080Orig1s039,040,041,045ltr.pdf 10/4/2012
AP06/11/2015SLR43047048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020080Orig1s048ltr.pdf 6/12/2015
AP06/11/2015SLR43055048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020080s048lbl.pdf 6/12/2015
AP011/19/2015SLR44552049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020080Orig1s049ltr.pdf 11/20/2015
AP011/19/2015SLR44592049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020080s049lbl.pdf 11/25/2015




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