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FDA Drug Application 020132 by GLAXOSMITHKLINE

Application Number020132
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
AP06/1/1995N15673000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm 1/17/2007
AP03/28/1996SCM       
AP02/13/1998SE2       
AP012/16/1997SCM       
AP02/24/1998SLR       
AP02/9/2001SLR       
AP02/9/2001SLR       
AP02/9/2001SLR       
AP06/25/2001SCM       
AP06/25/2001SLR       
AP08/11/2010SLR26207013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf 8/16/2010
AP08/11/2010SLR26250013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf 8/19/2010
AP07/28/2003SLR6507014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20132slr014,20626slr007,20080slr030ltr.pdf 8/15/2003
AP07/28/2003SLR17370014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020132_S014_IMITREX TABLETS, NASAL SPRAY INJ.pdf 7/24/2007
AP06/30/2003SCF14064015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020132_s015_ImitrexTOC.cfm 5/8/2006
AP17/28/2003SLR14064015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020132_s015_ImitrexTOC.cfm 5/8/2006
AP06/17/2004SLR9499018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20132slr018ltr.pdf 6/23/2004
AP08/11/2010SLR26208020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf 8/16/2010
AP08/11/2010SLR26251020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf 8/19/2010
AP08/11/2010SLR26209021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf 8/16/2010
AP08/11/2010SLR26252021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf 8/19/2010
AP08/11/2010SLR26210022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf 8/16/2010
AP08/11/2010SLR26253022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf 8/19/2010
AP03/1/2012SLR32000024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020132s024,s026ltr.pdf 3/5/2012
AP03/1/2012SLR32001026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020132s024,s026ltr.pdf 3/5/2012
AP03/1/2012SLR32054026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020132s024s026lbl.pdf 3/6/2012
AP011/25/2013SLR37932028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020132s028,020626s025lbl.pdf 11/26/2013
AP011/25/2013SLR37945028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020132Orig1s028,020626Orig1s025ltr.pdf 11/27/2013




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