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FDA Drug Application 050517 by MYLAN INSTITUTIONAL

Application Number050517
Application Type New Drug Application
Sponsor ApplicantMYLAN INSTITUTIONAL
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
AP010/18/1978N       
AP07/30/1996SE1       
AP02/28/1995SE2       
AP02/27/1997SLR9974031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/50-517s031_50-581s020_Mefoxin.cfm 8/10/2004
AP05/20/1996SLR       
AP010/27/1994SLR       
AP05/20/1996SLR       
AP011/30/1994SCS       
AP02/14/2000SLR10635038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-517s038_Mefoxin.cfm 11/22/2004
AP04/24/1997SLR9976039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/50-517S039_Mefoxin.pdf 8/10/2004
AP010/12/1999SCS       
AP010/19/2001SCS       
AP06/28/2004SLR9691042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50517slr042,045ltr.pdf 7/1/2004
AP05/7/2002SCS       
AP06/6/2002SCM       
AP06/28/2004SLR9692045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50517slr042,045ltr.pdf 7/1/2004
AP06/2/2004SLR9081046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50517slr046ltr.pdf 6/7/2004
AP06/2/2004SLR9133046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50517slr046_mefoxin_lbl.pdf 6/7/2004
AP09/17/2007SLR17890047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050517s047lbl.pdf 9/19/2007
AP09/17/2007SLR17986047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050517s047ltr.pdf 9/25/2007
AP02/4/2011SLR27812050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050517s050ltr.pdf 2/10/2011
AP05/10/2013SLR36051051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050517s051lbl.pdf 5/14/2013
AP05/10/2013SLR36053051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050517Orig1s051ltr.pdf 5/14/2013




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