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FDA Drug Application 018780 by LILLY

Application Number018780
Application Type New Drug Application
Sponsor ApplicantLILLY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/28/1982N       
AP012/2/1982SLR       
AP012/2/1982SCF       
AP01/31/1983SCS       
AP01/27/1983SLR       
AP03/14/1983SCS       
AP08/24/1983SLR       
AP010/12/1983SLR       
AP07/25/1984SCS       
AP01/26/1984SCS       
AP02/28/1984SLR       
AP012/26/1984SCS       
AP011/23/1984SCS       
AP03/8/1985SCS       
AP04/10/1986SCS       
AP09/15/1986SCS       
AP07/28/1987SLR       
AP05/7/1987SCS       
AP07/13/1987SLR       
AP05/28/1986SCS       
AP07/10/1987SLR       
AP06/10/1988SCS       
AP010/27/1987SCM       
AP03/24/1988SLR       
AP02/1/1989SCS       
AP07/29/1988SCS       
AP01/23/1989SLR       
AP08/17/1990SCS       
AP09/24/1990SCS       
AP011/15/1991SCS       
AP03/12/1991SLR       
AP01/11/1994SCP5929037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018780_s037.pdf 6/17/2003
AP01/27/1992SLR       
AP06/14/1994SCS       
AP05/10/1993SCM       
AP012/7/1992SCP       
AP03/31/1994SE2       
AP02/22/1995SLR       
AP03/9/1995SCS       
AP09/29/1995SLR       
AP011/9/1995SLR       
AP02/14/1996SCS       
AP02/15/1996SCS       
AP04/25/1996SCM       
AP07/26/1996SCS       
AP07/10/1996SLR       
AP07/26/1996SCS       
AP01/28/1997SCM       
AP04/16/1997SLR       
AP04/16/1997SCS       
AP19/22/2016SCM       
AP02/20/1998SCS       
AP08/6/1998SCP       
AP02/25/1999SCS       
AP011/2/1999SCS       
AP04/19/2000SCS       
AP08/29/2002SCS       
AP04/14/2003SLR5702066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780slr066ltr.pdf 5/29/2003
AP02/10/2003SLR4140067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018780s078lbl.pdf 3/5/2003
AP02/10/2003SLR9062067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm078,slr067ltr.pdf 6/7/2004
AP03/13/2002SCS       
AP010/10/2002SCS       
AP08/21/2002SCS       
AP08/21/2002SCS       
AP08/29/2002SCS       
AP08/29/2002SCS       
AP08/29/2002SCS       
AP010/25/2002SCS       
AP02/10/2003SCM4139078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018780s078lbl.pdf 3/5/2003
AP02/10/2003SCM9063078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm078,slr067ltr.pdf 6/7/2004
AP011/10/2003SCM6951080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm080ltr.pdf 11/25/2003
AP011/10/2003SCM7003080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18780scm080_humalog_lbl.pdf 12/1/2003
AP02/25/2005SCS11193086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18780s086,18781s080ltr.pdf 3/3/2005
AP02/25/2005SCS11203086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18780s086,18781s080lbl.pdf 3/3/2005
AP09/7/2007SLR17861094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf 9/11/2007
AP08/22/2007SLR17702095   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf 8/23/2007
AP08/22/2007SLR17721095   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s095,018781s089,019717s069,020100s032ltr.pdf 8/27/2007
AP09/10/2007SLR17839114   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s114lbl.pdf 9/11/2007
AP09/10/2007SLR17854114   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s114ltr.pdf 9/11/2007
AP03/25/2011SE328402120   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018780s120ltr.pdf 3/29/2011
AP03/25/2011SE328424120   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018780s120lbl.pdf 4/1/2011
AP03/21/2011SLR28319124   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018780s124ltr.pdf 3/24/2011
AP03/21/2011SLR28383124   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018780s124lbl.pdf 3/28/2011
AP03/29/2012SCM       
AP06/10/2010SLR25737128   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018780s128,018781s114,019717s094ltr.pdf 6/15/2010
AP06/10/2010SLR25778128   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018780s128lbl.pdf 6/24/2010
AP03/9/2013SLR35400132   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018780Orig1s132ltr.pdf 3/12/2013
AP03/9/2013SLR35441132   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018780s132lbl.pdf 3/12/2013
AP010/30/2011SLR30459133   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018780s133ltr.pdf 11/2/2011
AP012/29/2015SLR44918135   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018780Orig1s135s152ltr.pdf 12/30/2015
AP012/29/2015SLR44929135   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf 12/31/2015
AP01/9/2013SCM       
AP011/7/2012SCM       
AP05/10/2013SCM       
AP05/30/2013SCM       
AP05/31/2013SCM       
AP08/15/2013SCM       
AP03/18/2014SCM       
AP06/20/2014SCM       
AP09/23/2014SCM40619148   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018780s148lbl.pdf 9/26/2014
AP010/30/2014SCM       
AP12/25/2015SLR41994150   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s150lbl.pdf 3/3/2015
AP12/25/2015SLR42355150   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018780Orig1s150ltr.pdf 4/1/2015
AP010/8/2015SCM       
AP012/29/2015SLR44917152   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018780Orig1s135s152ltr.pdf 12/30/2015
AP012/29/2015SLR44930152   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf 12/31/2015
AP07/8/2016SLR46497153   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018780Orig1s153ltr.pdf 7/12/2016
AP02/26/2016SCM       
AP06/24/2016SCM       




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