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FDA Drug Application 018781 by LILLY

Application Number018781
Application Type New Drug Application
Sponsor ApplicantLILLY
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
AP010/28/1982N       
AP012/2/1982SLR       
AP012/2/1982SCF       
AP01/31/1983SCS       
AP01/27/1983SLR       
AP08/24/1983SLR       
AP010/12/1983SLR       
AP07/25/1984SCS       
AP02/29/1984SLR       
AP02/14/1985SCS       
AP012/26/1984SCS       
AP06/28/1988SCS       
AP07/31/1987SLR       
AP010/27/1987SCF       
AP07/28/1987SLR       
AP07/13/1987SLR       
AP07/13/1987SLR       
AP07/10/1987SLR       
AP010/27/1987SCM       
AP010/27/1987SCS       
AP010/27/1987SCM       
AP03/24/1988SLR       
AP03/3/1988SCS       
AP07/29/1988SCS       
AP01/23/1989SLR       
AP04/3/1991SLR23323027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018781_s027_Humulin N.pdf 9/16/2009
AP08/17/1990SCS       
AP09/24/1990SCS       
AP03/12/1991SLR       
AP01/11/1994SCP       
AP012/7/1992SCP       
AP010/27/1995SCF       
AP02/10/1995SCM       
AP02/22/1995SLR       
AP03/9/1995SCS       
AP09/29/1995SLR       
AP011/9/1995SLR       
AP02/15/1996SCS       
AP01/26/1996SCM       
AP05/31/1996SCS       
AP05/22/1996SCS       
AP07/26/1996SCS       
AP07/10/1996SLR       
AP01/28/1997SCM       
AP04/16/1997SLR       
AP02/20/1998SCS       
AP06/24/1997SCP       
AP08/6/1998SCP       
AP02/25/1999SCS       
AP011/5/2002SLR2260054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18781slr054ltr.pdf 11/5/2002
AP010/29/1999SCS       
AP07/7/2000SCM       
AP02/12/2003SLR4129057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf 3/5/2003
AP02/12/2003SLR9060057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr027,19717slr032,18781slr057ltr.pdf 6/7/2004
AP011/20/2003SLR6962060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781slr060,070ltr.pdf 11/25/2003
AP04/2/2002SCS       
AP010/31/2002SCS       
AP08/21/2002SCS       
AP08/21/2002SCS       
AP08/29/2002SCS       
AP08/29/2002SCS       
AP08/29/2002SCS       
AP011/20/2003SLR6963070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781slr060,070ltr.pdf 11/25/2003
AP06/22/2003SLR6039072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781slr072ltr.pdf 7/6/2003
AP06/22/2003SLR6077072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18781slr072_humulin_lbl.pdf 7/8/2003
AP011/19/2003SCM6931074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781scm074ltr.pdf 11/25/2003
AP011/19/2003SCM7014074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18781scm074_humulin_lbl.pdf 12/2/2003
AP04/21/2004SLR8437076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18781slr076ltr.pdf 4/29/2004
AP04/21/2004SLR8482076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781slr076_humulin_lbl.pdf 5/4/2004
AP08/27/2004SLR10140079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18781s079ltr.pdf 9/7/2004
AP19/3/2004SLR10140079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18781s079ltr.pdf 9/7/2004
AP08/27/2004SLR10141079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781s079lbl.pdf 9/7/2004
AP19/3/2004SLR10141079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781s079lbl.pdf 9/7/2004
AP02/25/2005SCS11194080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18780s086,18781s080ltr.pdf 3/3/2005
AP02/25/2005SCS11204080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18780s086,18781s080lbl.pdf 3/3/2005
AP011/9/2005SLR13066085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018781s025,060,065,085lbl.pdf 11/17/2005
AP011/9/2005SLR13086085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018781s025,060,065,085ltr.pdf 11/18/2005
AP09/7/2007SLR17860088   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf 9/11/2007
AP08/22/2007SLR17701089   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf 8/23/2007
AP08/22/2007SLR17720089   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s095,018781s089,019717s069,020100s032ltr.pdf 8/27/2007
AP03/16/2009SCS22026108   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf 3/17/2009
AP03/16/2009SCS22074108   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021018s049,018781s108,019717s087ltr.pdf 3/23/2009
AP03/21/2012SCM       
AP06/10/2010SLR25738114   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018780s128,018781s114,019717s094ltr.pdf 6/15/2010
AP06/10/2010SLR25777114   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018781s114lbl.pdf 6/24/2010
AP011/7/2013SLR37783118   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s118,s122ltr.pdf 11/12/2013
AP111/7/2013SLR37783118   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s118,s122ltr.pdf 11/12/2013
AP011/7/2013SLR37829118   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf 11/15/2013
AP111/7/2013SLR37829118   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf 11/15/2013
AP09/30/2014SCM40701120   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018781s120lbl.pdf 10/2/2014
AP03/9/2013SLR35399121   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s121ltr.pdf 3/12/2013
AP03/9/2013SLR35440121   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s121lbl.pdf 3/12/2013
AP011/7/2013SLR37782122   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s118,s122ltr.pdf 11/12/2013
AP111/7/2013SLR37782122   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s118,s122ltr.pdf 11/12/2013
AP011/7/2013SLR37830122   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf 11/15/2013
AP111/7/2013SLR37830122   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf 11/15/2013
AP011/7/2013SLR37831122   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf 11/15/2013
AP111/7/2013SLR37831122   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf 11/15/2013
AP012/3/2012SCM       
AP06/12/2013SCM       
AP02/15/2013SCM       
AP05/10/2013SCM       
AP03/25/2013SCM       
AP02/21/2013SCM       
AP08/21/2013SCM       
AP05/30/2013SCM       
AP05/31/2013SCM       
AP08/15/2013SCM       
AP012/12/2013SCM       
AP03/4/2014SCM       
AP03/18/2014SCM       
AP01/24/2014SCM       
AP04/3/2014SCM       
AP04/11/2014SCM       
AP012/9/2013SLR38020144   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s144ltr.pdf 12/13/2013
AP01/15/2014SLR38312145   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018781Orig1s145ltr.pdf 1/17/2014
AP06/10/2014SCM       
AP06/4/2014SCM       
AP09/12/2014SCM       
AP01/12/2015SCM       
AP02/25/2015SLR42758154   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018781s154lbl.pdf 5/8/2015
AP02/25/2015SLR41920154   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018781Orig1s154ltr.pdf 2/27/2015
AP03/3/2015SCM       
AP03/12/2015SLR42145156   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018781Orig1s156ltr.pdf 3/13/2015
AP03/12/2015SLR42174156   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018781s156lbl.pdf 3/17/2015
AP07/15/2015SCM       
AP010/8/2015SCM       
AP010/20/2015SCM       
AP02/19/2016SCM       
AP04/22/2016SCM       
AP04/5/2016SCM       
AP09/2/2016SCM       




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