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FDA Drug Application 019640 by LILLY

Application Number019640
Application Type New Drug Application
Sponsor ApplicantLILLY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/8/1987N       
AP06/23/1987SCF       
AP05/10/1989SE3       
AP04/4/1989SLR       
AP04/23/1990SCS       
AP010/11/1990SLR       
AP03/18/1992SLR       
AP012/14/1993SCS       
AP011/18/1993SLR       
AP04/15/1994SE2       
AP01/11/1995SCS       
AP09/13/1995SCS       
AP09/22/1995SLR       
AP08/1/1996SE1       
AP012/15/1995SCM       
AP011/7/1996SLR       
AP011/22/1996SCS       
AP08/5/1996SLR       
AP03/11/1997SE14290018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640ap.pdf 3/11/1997
AP03/11/1997SLR4291019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640ap.pdf 3/11/1997
AP06/13/1997SCS20565020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640_s020_HUMATROPE 5.pdf 8/11/2008
AP010/3/1997SLR       
AP02/4/1999SCF21574022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019640_s022_HUMATROPE.pdf 1/12/2009
AP09/7/1999SCM       
AP06/10/2002SLR2228025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19640s025ltr.pdf 6/10/2002
AP02/12/2001SLR       
AP01/17/2001SCS       
AP05/1/2001SCS       
AP05/22/2001SCM       
AP012/4/2002SLR2227031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19640slr031ltr.pdf 12/4/2002
AP03/24/2003SLR17051032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019640_S032_HUMATROPE_AP.pdf 7/6/2007
AP03/24/2003SLR4505032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19640slr032ltr.pdf 3/26/2003
AP07/25/2003SE16488033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19640se1-033_humatropen_lbl.pdf 8/14/2003
AP07/25/2003SE19058033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19640se1-033ltr.pdf 6/7/2004
AP07/25/2003SE116193033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019640_S033_HUMATROPE_AP.pdf 4/9/2007
AP09/22/2004SLR10290040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19640s040rev2.pdf 9/29/2004
AP09/22/2004SLR10291040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19640s040lbl.pdf 9/29/2004
AP010/12/2005S12977045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019640s045ltr.pdf 10/25/2005
AP010/12/2005S12978045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019640s045lbl.pdf 10/25/2005
AP06/28/2006SCP14412046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s046ltr.pdf 7/3/2006
AP010/26/2006SLR15283047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s047,019640s052ltr.pdf 10/27/2006
AP010/26/2006SLR15286047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf 10/27/2006
AP010/26/2006SCS15284052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s047,019640s052ltr.pdf 10/27/2006
AP010/26/2006SCS15285052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf 10/27/2006
AP011/1/2006SE115294058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s058lbl.pdf 11/6/2006
AP011/1/2006SE115313058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s058ltr.pdf 11/6/2006
AP03/12/2009SE122011068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019640s068ltr.pdf 3/17/2009
AP03/12/2009SE122030068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019640s068lbl.pdf 3/17/2009
AP01/12/2009SCS21629070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019640s070ltr.pdf 1/14/2009
AP07/28/2010SLR26039078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019640s078ltr.pdf 7/30/2010
AP07/28/2010SLR26070078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019640s078_2lbl.pdf 7/31/2010
AP02/23/2011SLR27978084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019640s084ltr.pdf 2/28/2011
AP02/23/2011SLR28033084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s084lbl.pdf 3/4/2011
AP08/22/2011SLR29851086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s086lbl.pdf 8/22/2011
AP08/22/2011SLR29895086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019640s086ltr.pdf 8/26/2011
AP05/24/2013SCM       
AP07/30/2014SLR40079092   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019640Orig1s092ltr.pdf 7/31/2014
AP07/30/2014SLR40083092   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019640s092lbl.pdf 7/31/2014
AP01/24/2014SCM       
AP04/11/2014SCM       
AP08/11/2014SCM       
AP09/12/2014SCM       
AP011/10/2014SCM       




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