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FDA Drug Application 050672 by GLAXOSMITHKLINE

Application Number050672
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
AP06/30/1994N       
AP09/13/1996SLR       
AP012/14/1995SLR       
AP07/27/1999SCE       
AP012/23/1996SLR       
AP09/13/1996SLR       
AP08/8/1995SCS       
AP011/9/1995SLR       
AP04/29/1997SCS       
AP012/23/1996SLR       
AP06/4/1997SLR       
AP011/19/1997SCM       
AP03/24/1998SLR       
AP03/29/2002SLR2336013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s31ltr.pdf 3/29/2002
AP03/29/2002SLR2337013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf 3/29/2002
AP08/24/1999SE82332014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50605ltr.pdf 8/24/1999
AP08/24/1999SE82333014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50605S032_Ceftin.pdf 8/24/1999
AP03/2/1999SCP       
AP04/23/1999SCM       
AP09/25/2000SCS       
AP04/11/2002SLR2330018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s33ltr.pdf 4/11/2002
AP04/11/2002SLR2331018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf 4/11/2002
AP07/3/2001SCM       
AP04/13/2001SCS       
AP09/18/2001SCS       
AP06/3/2004SLR9076025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50605slr039,50672slr025ltr.pdf 6/7/2004
AP06/3/2004SLR9137025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50605slr039,50672slr025_ceftin_lbl.pdf 6/7/2004
AP08/1/2007SLR17449028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050672s028lbl.pdf 8/2/2007
AP08/1/2007SLR17461028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050672s028ltr.pdf 8/2/2007
AP09/20/2014SLR40542029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf 9/22/2014
AP09/20/2014SLR40566029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050672Orig1s029,s032ltr.pdf 9/23/2014
AP09/20/2014SLR40567032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050672Orig1s029,s032ltr.pdf 9/23/2014
AP09/20/2014SLR40543032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf 9/22/2014
AP06/26/2015SLR43178033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s047,050672s033lbl.pdf 7/1/2015
AP06/26/2015SLR43261033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s047,050672Orig1s033ltr.pdf 7/7/2015
AP08/26/2015SLR43736034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.pdf 8/27/2015
AP08/26/2015SLR43741034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s048,050672Orig1s034ltr.pdf 8/28/2015




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