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FDA Drug Application 050605 by GLAXOSMITHKLINE

Application Number050605
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/28/1987N       
AP08/19/1991SLR       
AP08/19/1991SLR       
AP03/13/1996SE1       
AP01/31/1992SE1       
AP08/19/1991SLR       
AP01/27/1993SLR       
AP08/9/1991SCM       
AP01/27/1993SLR       
AP01/31/1992SCM       
AP010/18/1993SLR       
AP06/28/1993SCS       
AP012/19/1996SE1       
AP06/30/1994SLR       
AP08/30/1995SCM       
AP012/23/1996SLR       
AP09/13/1996SLR       
AP09/13/1996SLR       
AP012/6/1996SE1       
AP09/17/1997SE2       
AP012/23/1996SLR       
AP06/4/1997SLR       
AP011/19/1997SCM       
AP01/16/1998SCM       
AP03/24/1998SLR       
AP03/29/2002SLR2334031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s31ltr.pdf 3/29/2002
AP03/29/2002SLR2335031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf 3/29/2002
AP08/24/1999SE81388032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50605ltr.pdf 8/24/1999
AP08/24/1999SE81389032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50605S032_Ceftin.pdf 8/24/1999
AP04/11/2002SLR2328033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s33ltr.pdf 4/11/2002
AP04/11/2002SLR2329033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf 4/11/2002
AP07/3/2001SCM       
AP04/13/2001SCS       
AP012/20/2001SCM       
AP07/24/2002SLR2327037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605slr037ltr.pdf 7/24/2002
AP06/3/2004SLR9075039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50605slr039,50672slr025ltr.pdf 6/7/2004
AP06/3/2004SLR9134039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50605slr039,50672slr025_ceftin_lbl.pdf 6/7/2004
AP07/23/2007SLR17360042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050605s042lbl.pdf 7/24/2007
AP07/23/2007SLR17387042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050605s042ltr.pdf 7/27/2007
AP09/20/2014SLR40544043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf 9/22/2014
AP09/20/2014SLR40571043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050605Orig1s043,s046ltr.pdf 9/23/2014
AP09/20/2014SLR40545046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050605s043s046lbl.pdf 9/22/2014
AP09/20/2014SLR40572046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050605Orig1s043,s046ltr.pdf 9/23/2014
AP06/26/2015SLR43179047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s047,050672s033lbl.pdf 7/1/2015
AP06/26/2015SLR43260047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s047,050672Orig1s033ltr.pdf 7/7/2015
AP08/26/2015SLR43737048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.pdf 8/27/2015
AP08/26/2015SLR43740048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s048,050672Orig1s034ltr.pdf 8/28/2015




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