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FDA Drug Application 020626 by GLAXOSMITHKLINE

Application Number020626
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
AP08/26/1997N15674000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm 1/17/2007
AP08/26/1997N24934000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020626_imitrex_toc.cfm 3/3/2010
AP06/1/2000SLR20482001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020626_s001_IMITREX_NASAL_SPRAY.pdf 8/4/2008
AP06/1/2000SLR20481002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020626_s002_IMITREX_NASAL_SPRAY.pdf 8/4/2008
AP012/11/2000SLR       
AP010/13/2004SE510415004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20626s004ltr.pdf 10/15/2004
AP010/13/2004SE510418004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20626s004lbl.pdf 10/15/2004
AP05/10/2002SLR1883006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20626s6ltr.pdf 5/10/2002
AP07/28/2003SLR6508007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20132slr014,20626slr007,20080slr030ltr.pdf 8/15/2003
AP07/28/2003SLR17371007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020626_S007_IMITREX TABLETS, NASAL SPRAY INJECTION.pdf 7/24/2007
AP07/21/2010SLR26055013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf 7/31/2010
AP07/21/2010SLR26026013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020626s013,s015,s016ltr.pdf 7/28/2010
AP07/21/2010SLR26027015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020626s013,s015,s016ltr.pdf 7/28/2010
AP07/21/2010SLR26056015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf 7/31/2010
AP07/21/2010SLR26057016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf 7/31/2010
AP07/21/2010SLR26028016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020626s013,s015,s016ltr.pdf 7/28/2010
AP03/1/2012SLR32002018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020626s018,s022ltr.pdf 3/5/2012
AP03/1/2012SLR32003022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020626s018,s022ltr.pdf 3/5/2012
AP03/1/2012SLR32055022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020626s018s022lbl.pdf 3/6/2012
AP011/25/2013SLR37931025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020132s028,020626s025lbl.pdf 11/26/2013
AP011/25/2013SLR37946025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020132Orig1s028,020626Orig1s025ltr.pdf 11/27/2013
AP03/25/2016SCM       




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