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FDA Drug Application 020604 by EMD SERONO

Application Number	020604
Application Type	New Drug Application
Sponsor Applicant	EMD SERONO
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New manufacturer
Therapeutic Potential	Priority
Orphan Code	V

Action Type	Duplicate Counter	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	0	8/23/1996	N
AP	0	1/16/1998	SLR
AP	0	7/25/1997	SCS
AP	0	1/21/1998	SCM
AP	0	7/9/1998	SCM
AP	0	7/9/1998	SCS
AP	0	4/4/2000	SLR
AP	0	3/28/2000	SCM
AP	0	9/18/2000	SCE
AP	0	7/17/2000	SLR
AP	0	10/27/2000	SLR
AP	0	4/11/2000	SCM
AP	0	7/19/2000	SCS	23364	012	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020604_s012_SAIZEN INJECTION.pdf	9/16/2009
AP	0	8/17/2000	SCS
AP	0	6/13/2001	SLR
AP	0	5/3/2001	SCM
AP	0	9/6/2001	SLR
AP	0	7/19/2001	SCM
AP	0	9/6/2002	SCS
AP	0	11/19/2001	SCS
AP	0	12/3/2001	SCS
AP	0	12/20/2002	SCM
AP	0	12/31/2002	SCM
AP	0	10/17/2002	SCS
AP	0	12/1/2003	SLR	7053	026	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21597,20604slr026ltr.pdf	12/4/2003
AP	0	12/1/2003	SLR	7066	026	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604s026_zorbtive_lbl.pdf	12/8/2003
AP	0	12/1/2003	SLR	17525	026	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020604_S026_ZORBITIVE.pdf	8/6/2007
AP	0	8/29/2003	SE7	6605	027	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604se7-027_serostim_lbl.pdf	9/9/2003
AP	0	8/29/2003	SE7	6606	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20604se7-027ltr.pdf	9/9/2003
AP	0	8/29/2003	SE7	23365	027	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020604_s027_SEROSTIM.pdf	9/16/2009
AP	0	2/11/2005	SCF	11125	029	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20604s029ltr.pdf	2/17/2005
AP	0	2/11/2005	SCF	11132	029	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20604s029lbl.pdf	2/17/2005
AP	0	7/9/2004	SCP	9736	030	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19764scp,20604scp030ltr.pdf	7/14/2004
AP	0	7/9/2004	SCP	9739	030	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764scp,20604scp030_serostim_lbl.pdf	7/14/2004
AP	0	8/24/2005	SLR	12673	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020604s031ltr.pdf	8/31/2005
AP	0	8/24/2005	SLR	12687	031	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020604s031lbl.pdf	8/31/2005
AP	0	9/21/2006	SCS	14951	034	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020604s034ltr.pdf	9/25/2006
AP	0	9/21/2006	SCS	14971	034	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020604s034lbl.pdf	9/25/2006
AP	0	11/27/2006	SCS	15422	035	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020604s035lbl.pdf	12/4/2006
AP	0	11/27/2006	SCS	15427	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020604s035ltr.pdf	12/4/2006
AP	0	7/13/2007	SLR	17288	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s040lbl.pdf	7/16/2007
AP	0	7/13/2007	SLR	17345	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s040ltr.pdf	7/24/2007
AP	0	7/13/2007	SLR	27870	040	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020604_s040_serostim.pdf	2/15/2011
AP	0	8/27/2007	SLR	17726	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044lbl.pdf	8/30/2007
AP	0	8/27/2007	SLR	17727	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s044ltr.pdf	8/30/2007
AP	0	8/27/2007	SLR	17740	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044_2lbl.pdf	9/4/2007
AP	0	8/27/2007	SLR	17744	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s044_v2ltr.pdf	9/4/2007
AP	1	8/30/2007	SLR	17726	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044lbl.pdf	8/30/2007
AP	1	8/30/2007	SLR	17727	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s044ltr.pdf	8/30/2007
AP	1	8/30/2007	SLR	17740	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044_2lbl.pdf	9/4/2007
AP	1	8/30/2007	SLR	17744	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s044_v2ltr.pdf	9/4/2007
AP	0	8/31/2009	SLR	23971	048	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020604s048ltr.pdf	11/19/2009
AP	0	4/3/2012	SLR	32357	049	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020604s049,019764s049ltr.pdf	4/5/2012
AP	0	4/3/2012	SLR	32365	049	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020604s049lbl.pdf	4/6/2012
AP	0	11/20/2012	SCM
AP	0	2/8/2013	SCM
AP	0	1/31/2013	SCM
AP	0	2/15/2013	SCM
AP	0	2/28/2013	SCM
AP	1	12/17/2013	SCM
AP	0	4/5/2013	SCM
AP	0	12/11/2013	SCM
AP	0	12/12/2013	SCM
AP	0	6/16/2014	SLR	39586	078	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020604Orig1s078ltr.pdf	6/19/2014
AP	0	6/16/2014	SLR	39625	078	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020604s078lbl.pdf	6/23/2014
AP	0	9/17/2014	SCM
AP	0	9/30/2014	SCM
AP	0	8/11/2014	SCM

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