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FDA Drug Application 019640 by LILLY

Application Number	019640
Application Type	New Drug Application
Sponsor Applicant	LILLY
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New manufacturer
Therapeutic Potential	Priority
Orphan Code	V

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	3/8/1987	N
AP	6/23/1987	SCF
AP	5/10/1989	SE3
AP	4/4/1989	SLR
AP	4/23/1990	SCS
AP	10/11/1990	SLR
AP	3/18/1992	SLR
AP	12/14/1993	SCS
AP	11/18/1993	SLR
AP	4/15/1994	SE2
AP	1/11/1995	SCS
AP	9/13/1995	SCS
AP	9/22/1995	SLR
AP	8/1/1996	SE1
AP	12/15/1995	SCM
AP	11/7/1996	SLR
AP	11/22/1996	SCS
AP	8/5/1996	SLR
AP	3/11/1997	SE1	4290	018	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640ap.pdf	3/11/1997
AP	3/11/1997	SLR	4291	019	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640ap.pdf	3/11/1997
AP	6/13/1997	SCS	20565	020	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640_s020_HUMATROPE 5.pdf	8/11/2008
AP	10/3/1997	SLR
AP	2/4/1999	SCF	21574	022	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019640_s022_HUMATROPE.pdf	1/12/2009
AP	9/7/1999	SCM
AP	6/10/2002	SLR	2228	025	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19640s025ltr.pdf	6/10/2002
AP	2/12/2001	SLR
AP	1/17/2001	SCS
AP	5/1/2001	SCS
AP	5/22/2001	SCM
AP	12/4/2002	SLR	2227	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19640slr031ltr.pdf	12/4/2002
AP	3/24/2003	SLR	4505	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19640slr032ltr.pdf	3/26/2003
AP	3/24/2003	SLR	17051	032	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019640_S032_HUMATROPE_AP.pdf	7/6/2007
AP	7/25/2003	SE1	6488	033	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19640se1-033_humatropen_lbl.pdf	8/14/2003
AP	7/25/2003	SE1	9058	033	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19640se1-033ltr.pdf	6/7/2004
AP	7/25/2003	SE1	16193	033	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019640_S033_HUMATROPE_AP.pdf	4/9/2007
AP	9/22/2004	SLR	10290	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19640s040rev2.pdf	9/29/2004
AP	9/22/2004	SLR	10291	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19640s040lbl.pdf	9/29/2004
AP	10/12/2005	S	12977	045	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019640s045ltr.pdf	10/25/2005
AP	10/12/2005	S	12978	045	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019640s045lbl.pdf	10/25/2005
AP	6/28/2006	SCP	14412	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s046ltr.pdf	7/3/2006
AP	10/26/2006	SLR	15283	047	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s047,019640s052ltr.pdf	10/27/2006
AP	10/26/2006	SLR	15286	047	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf	10/27/2006
AP	10/26/2006	SCS	15284	052	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s047,019640s052ltr.pdf	10/27/2006
AP	10/26/2006	SCS	15285	052	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf	10/27/2006
AP	11/1/2006	SE1	15294	058	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s058lbl.pdf	11/6/2006
AP	11/1/2006	SE1	15313	058	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s058ltr.pdf	11/6/2006
AP	3/12/2009	SE1	22011	068	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019640s068ltr.pdf	3/17/2009
AP	3/12/2009	SE1	22030	068	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019640s068lbl.pdf	3/17/2009
AP	1/12/2009	SCS	21629	070	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019640s070ltr.pdf	1/14/2009
AP	7/28/2010	SLR	26039	078	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019640s078ltr.pdf	7/30/2010
AP	7/28/2010	SLR	26070	078	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019640s078_2lbl.pdf	7/31/2010
AP	2/23/2011	SLR	27978	084	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019640s084ltr.pdf	2/28/2011
AP	2/23/2011	SLR	28033	084	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s084lbl.pdf	3/4/2011
AP	8/22/2011	SLR	29851	086	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s086lbl.pdf	8/22/2011
AP	8/22/2011	SLR	29895	086	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019640s086ltr.pdf	8/26/2011
AP	5/24/2013	SCM
AP	7/30/2014	SLR	40079	092	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019640Orig1s092ltr.pdf	7/31/2014
AP	7/30/2014	SLR	40083	092	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019640s092lbl.pdf	7/31/2014
AP	1/24/2014	SCM
AP	4/11/2014	SCM
AP	8/11/2014	SCM
AP	9/12/2014	SCM
AP	11/10/2014	SCM

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