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FDA Drug Application 020522 by GENENTECH

Application Number	020522
Application Type	New Drug Application
Sponsor Applicant	GENENTECH
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document Title	Document URL	Document Date
AP	12/29/1995	N
AP	8/7/1996	SCS
AP	3/24/1997	SE1	4314	002		http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020522_s002ap.pdf	3/24/1997
AP	9/12/1997	SCS
AP	12/17/1997	SE1	4315	004		http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020522a_s004.pdf	12/17/1997
AP	7/9/1998	SCS
AP	10/26/1998	SCM
AP	9/25/1998	SCS
AP	9/25/1998	SCS
AP	12/1/1999	SE8	3053	009		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20522S9LTR.PDF	12/1/1999
AP	12/1/1999	SE8	5635	009		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20522S9.PDF	5/15/2003
AP	11/3/1999	SCM
AP	11/24/1999	SLR	17512	011		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020522_S011_NUTROPIN FOR INJ.pdf	8/6/2007
AP	10/13/1999	SCS
AP	4/13/2000	SE2	1356	013		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20522S13LTR.PDF	4/13/2000
AP	4/13/2000	SE2	6110	013		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-522s013_Somatropin.cfm	7/8/2003
AP	4/13/2000	SE2	9284	013		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-522S013_Somatropin_prntlbl.pdf	6/10/2004
AP	9/17/2001	SCS
AP	5/2/2001	SCM
AP	9/17/2001	SCM
AP	4/22/2002	SCP	3051	017		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20522s017.pdf	4/22/2002
AP	4/22/2002	SCP	3052	017		http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20522s17lbl.pdf	4/22/2002
AP	6/28/2005	SE1	11910	021		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s021,022_rel2_ltr.pdf	6/29/2005
AP	6/28/2005	SE1	11924	021		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf	6/29/2005
AP	6/28/2005	SE1	12217	021	Additional App Ltr	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf	7/22/2005
AP	6/28/2005	SE1	12280	021	Additional Label	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022_rel2_lbl.pdf	7/26/2005
AP	6/28/2005	SLR	11911	022		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s021,022_rel2_ltr.pdf	6/29/2005
AP	6/28/2005	SLR	11925	022		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf	6/29/2005
AP	6/28/2005	SLR	12218	022	Additional App Ltr	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf	7/22/2005
AP	6/28/2005	SLR	12281	022	Additional Label	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022_rel2_lbl.pdf	7/26/2005
AP	1/3/2008	SCM	18737	026		http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf	1/8/2008
AP	1/3/2008	SCM	18802	026		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf	1/9/2008
AP	11/18/2005	SE8	13129	027		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s027lbl.pdf	11/22/2005
AP	11/18/2005	SE8	13130	027		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s027ltr.pdf	11/22/2005
AP	2/15/2007	SLR	15857	033		http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019676s030,020522s033lbl.pdf	2/21/2007
AP	2/15/2007	SLR	15886	033		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019676s030, 020522s033ltr.pdf	2/23/2007
AP	1/3/2008	SCS	18738	036		http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf	1/8/2008
AP	1/3/2008	SCS	18803	036		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf	1/9/2008
AP	1/3/2008	SCS	18739	037		http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf	1/8/2008
AP	1/3/2008	SCS	18804	037		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf	1/9/2008
AP	4/10/2012	SLR	32409	045		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019676s042,020522s045ltr.pdf	4/12/2012
AP	4/10/2012	SLR	32450	045		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020522s045lbl.pdf	4/17/2012
AP	7/18/2013	SCM
AP	9/17/2013	SCM
AP	6/16/2014	SLR	39555	051		http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020522s051lbl.pdf	6/17/2014
AP	6/16/2014	SLR	39580	051		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020522Orig1s051ltr.pdf	6/18/2014
AP	5/15/2014	SCM
AP	5/26/2015	SCM
AP	6/23/2015	SCM
AP	1/13/2016	SCM
AP	2/26/2016	SCM
AP	3/17/2016	SCM
AP	5/18/2016	SCM

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