Back to FDA Applications sponsored by LILLY

FDA Drug Application 019717 by LILLY

Application Number019717
Application Type New Drug Application
Sponsor ApplicantLILLY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/25/1989N       
AP05/26/1989SCS       
AP05/23/1990SLR       
AP04/22/1990SCS       
AP09/24/1990SCS       
AP03/12/1991SLR       
AP01/11/1994SCP       
AP01/27/1992SLR       
AP02/23/1994SCS       
AP012/7/1992SCP       
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       
AP04/18/1997SLR       
AP02/20/1998SCS       
AP07/16/1997SCS       
AP08/6/1998SCP       
AP02/25/1999SCS       
AP011/1/2002SLR2231030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19717slr030ltr.pdf 11/1/2002
AP02/12/2003SLR4126032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf 3/5/2003
AP02/12/2003SLR9059032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr027,19717slr032,18781slr057ltr.pdf 6/7/2004
AP02/5/2002SCS2261035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19-717S035.pdf 2/5/2002
AP04/2/2002SCS       
AP02/28/2002SCS       
AP03/14/2002SCS       
AP03/22/2002SCS       
AP03/29/2002SCS       
AP010/3/2002SLR2229041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19717slr041ltr.pdf 10/3/2002
AP010/3/2002SLR2230041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19717s41lbl.pdf 10/3/2002
AP010/25/2002SCS       
AP08/21/2002SCS       
AP08/21/2002SCS       
AP08/29/2002SCS       
AP08/29/2002SCS       
AP08/29/2002SCS       
AP09/25/2002SCM       
AP011/17/2003SLR6935050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19717slr050ltr.pdf 11/25/2003
AP011/17/2003SLR7015050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717slr050_humilin_lbl.pdf 12/2/2003
AP06/22/2003SLR6042052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19717slr052ltr.pdf 7/6/2003
AP06/22/2003SLR6076052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717slr052_humulin_lbl.pdf 7/8/2003
AP011/19/2003SCM7024054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19717scm054ltr.pdf 12/2/2003
AP011/19/2003SCM7030054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717scm054_humulin_lbl.pdf 12/2/2003
AP04/22/2004SLR8438058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19717slr058ltr.pdf 4/29/2004
AP04/22/2004SLR8483058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19717slr058_humulin_lbl.pdf 5/4/2004
AP011/10/2004SLR10594060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19717s060ltr.pdf 11/16/2004
AP011/10/2004SLR10609060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19717s060lbl.pdf 11/16/2004
AP011/9/2005SLR       
AP09/7/2007SLR17859068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf 9/11/2007
AP08/22/2007SLR17700069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf 8/23/2007
AP08/22/2007SLR17719069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s095,018781s089,019717s069,020100s032ltr.pdf 8/27/2007
AP03/16/2009SCS22075087   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021018s049,018781s108,019717s087ltr.pdf 3/23/2009
AP03/21/2012SCM       
AP06/10/2010SLR25739094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018780s128,018781s114,019717s094ltr.pdf 6/15/2010
AP06/10/2010SLR25776094   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019717s094lbl.pdf 6/24/2010
AP011/7/2013SLR37800098   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019717Orig1s098,s101ltr.pdf 11/13/2013
AP011/7/2013SLR37833098   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s098s101lbl.pdf 11/15/2013
AP03/9/2013SLR35414099   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019717Orig1s099ltr.pdf 3/12/2013
AP03/9/2013SLR35439099   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s099lbl.pdf 3/12/2013
AP011/7/2013SLR37801101   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019717Orig1s098,s101ltr.pdf 11/13/2013
AP011/7/2013SLR37832101   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s098s101lbl.pdf 11/15/2013
AP06/12/2013SCM       
AP02/15/2013SCM       
AP05/10/2013SCM       
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       
AP012/9/2013SLR38021123   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019717Orig1s123ltr.pdf 12/13/2013
AP01/15/2014SLR38313124   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019717Orig1s124ltr.pdf 1/17/2014
AP06/4/2014SCM       
AP09/12/2014SCM       
AP02/25/2015SLR41921133   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019717Orig1s133ltr.pdf 2/27/2015
AP02/25/2015SLR41967133   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019717s133lbl.pdf 3/2/2015
AP03/12/2015SLR42139135   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019717Orig1s135ltr.pdf 3/13/2015
AP03/12/2015SLR42173135   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019717s135lbl.pdf 3/17/2015




Back to FDA Applications sponsored by LILLY