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FDA Drug Application 020280 by PHARMACIA AND UPJOHN

Application Number	020280
Application Type	New Drug Application
Sponsor Applicant	PHARMACIA AND UPJOHN
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New manufacturer
Therapeutic Potential	Standard
Orphan Code

Action Type	Duplicate Counter	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	0	8/24/1995	N
AP	0	12/20/1995	SLR
AP	0	4/24/1996	SCM
AP	0	4/19/1996	SLR
AP	0	5/24/1996	SCS
AP	0	7/15/1996	SCM
AP	0	11/19/1996	SCS
AP	0	10/23/1996	SCS
AP	0	10/31/1997	SE1	27745	008	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020280s008.pdf	2/4/2011
AP	0	1/27/1998	SCS
AP	0	1/5/1998	SCS
AP	0	8/4/1998	SCS
AP	0	8/18/1998	SCS
AP	0	4/30/1999	SCS
AP	0	7/30/1998	SCS
AP	0	2/24/1999	SCM
AP	0	4/27/1999	SCS
AP	0	4/30/1999	SCS
AP	0	1/19/2000	SCS
AP	0	7/11/2000	SCM
AP	0	4/11/2000	SCM
AP	0	6/20/2000	SE1	1488	023	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20280S23LTR.PDF	6/20/2000
AP	0	5/12/2000	SCS
AP	0	7/11/2000	SLR
AP	0	5/26/2000	SCS
AP	0	7/31/2000	SCS
AP	0	8/18/2000	SLR
AP	0	10/5/2000	SCM
AP	0	7/21/2000	SCS
AP	0	7/25/2001	SE1	2110	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20280s31ltr.pdf	7/25/2001
AP	0	7/25/2001	SE1	2111	031	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20280s31lbl.pdf	7/25/2001
AP	0	7/25/2001	SE1	2112	031	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-280S031_Genotropin.cfm	7/25/2001
AP	0	11/7/2000	SCM
AP	0	12/8/2000	SCM
AP	0	1/26/2001	SCS
AP	0	7/9/2001	SCM
AP	0	9/21/2001	SCM
AP	0	1/29/2002	SCS
AP	0	3/28/2003	SCM	5281	038	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280scm038ltr.pdf	4/15/2003
AP	0	8/15/2002	SCM
AP	0	5/12/2003	SCS	5663	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20280scs040_genotropin_lbl.pdf	5/29/2003
AP	0	5/12/2003	SCS	5811	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280scs040ltr.pdf	6/8/2003
AP	0	11/5/2002	SCS
AP	0	10/31/2003	SLR	6979	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280slr044ltr.pdf	11/25/2003
AP	0	4/27/2006	SE1	13998	049	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020280s049lbl.pdf	5/1/2006
AP	0	4/27/2006	SE1	14034	049	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020280s049LTR.pdf	5/1/2006
AP	0	4/27/2006	SE1	27029	049	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020280_s049_genotropin_medr.pdf	4/1/2006
AP	0	7/22/2007	SCS	17333	055	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020280s055ltr.pdf	7/24/2007
AP	0	7/22/2007	SCS	17351	055	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s055lbl.pdf	7/24/2007
AP	1	8/10/2007	SCS	17333	055	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020280s055ltr.pdf	7/24/2007
AP	1	8/10/2007	SCS	17351	055	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s055lbl.pdf	7/24/2007
AP	0	3/14/2007	SLR	16024	057	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020280s057ltr.pdf	3/15/2007
AP	0	3/14/2007	SLR	16038	057	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s057lbl.pdf	3/15/2007
AP	0	6/12/2008	SE1	20012	060	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020280s060ltr.pdf	6/13/2008
AP	0	6/12/2008	SE1	20029	060	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s060lbl.pdf	6/18/2008
AP	0	6/12/2008	SE1	20215	060	http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020280se1-060_SUMR.pdf	7/16/2008
AP	0	1/5/2009	SCS	21531	061	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s061lbl.pdf	1/6/2009
AP	0	1/5/2009	SCS	21546	061	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020280s061ltr.pdf	1/6/2009
AP	0	5/20/2009	SCM	22615	064	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s064lbl.pdf	5/25/2009
AP	0	5/20/2009	SCM	22619	064	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020280s064ltr.pdf	5/26/2009
AP	0	12/15/2008	SLR	21369	066	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020280s066ltr.pdf	12/19/2008
AP	0	12/15/2008	SLR	21475	066	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s066lbl.pdf	1/2/2009
AP	0	2/2/2010	SLR	24762	068	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020280s068lbl.pdf	2/16/2010
AP	0	2/2/2010	SLR	24784	068	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020280s068ltr.pdf	2/16/2010
AP	0	5/17/2011	SLR	28858	071	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020280s071ltr.pdf	5/19/2011
AP	0	5/17/2011	SLR	28905	071	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020280s071lbl.pdf	5/23/2011
AP	0	2/6/2012	SLR	31694	072	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020280s072lbl.pdf	2/6/2012
AP	0	2/6/2012	SLR	31711	072	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020280s072ltr.pdf	2/8/2012
AP	0	4/19/2013	SCM
AP	0	10/17/2013	SCM
AP	0	9/25/2014	SLR	40645	077	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020280Orig1s077ltr.pdf	9/29/2014
AP	0	9/25/2014	SLR	40654	077	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020280s077lbl.pdf	9/30/2014
AP	0	6/22/2015	SLR	43109	078	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020280Orig1s078ltr.pdf	6/24/2015
AP	0	6/22/2015	SLR	43113	078	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020280s078lbl.pdf	6/24/2015
AP	0	9/6/2016	SLR	46984	079	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020280Orig1s079ltr.pdf	9/7/2016
AP	0	9/6/2016	SLR	46997	079	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020280s079lbl.pdf	9/8/2016
AP	0	2/16/2015	SCM
AP	0	9/10/2015	SCM
AP	0	12/28/2015	SCM
AP	0	6/16/2016	SCM
AP	0	8/15/2016	SCM

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