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FDA Drug Application 021130 by PHARMACIA AND UPJOHN

Application Number	021130
Application Type	New Drug Application
Sponsor Applicant	PHARMACIA AND UPJOHN
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	4/18/2000	N	1439	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21130ltr.pdf	4/18/2000
AP	4/18/2000	N	1440	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf	4/18/2000
AP	4/18/2000	N	2248	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21130_Zyvox.cfm	4/18/2000
AP	2/6/2001	SLR
AP	12/19/2002	SLR	4973	002	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21130slr002,21131slr002,21132slr002_zyvox_lbl.pdf	4/7/2003
AP	12/19/2002	SLR	9683	002	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21130slr002,21131slr002,21132slr002ltr.pdf	7/1/2004
AP	12/19/2002	SE5	4978	003	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21132se5-003,21131se5-003,21130se5-003_zyvox_lbl.pdf	4/7/2003
AP	12/19/2002	SE5	9681	003	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21132se5-003,21131se5-003,21130se5-003ltr.pdf	7/1/2004
AP	12/19/2002	SE5	11904	003	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-130s003_21131s003_21132s003_ZyvoxTOC.cfm	6/27/2005
AP	7/22/2003	SE8	6182	004	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21130se8-004,21131se8-004,21132se8-004ltr.pdf	7/28/2003
AP	1/5/2004	SLR	7523	005	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130slr005,21131slr006,21132slr005ltr.pdf	1/14/2004
AP	6/23/2004	SE5	9538	006	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21130se5-006,21131se5-007,21132se5-006ltr.pdf	6/25/2004
AP	6/23/2004	SE5	9553	006	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21130se5-006,21131se5-007,21132se5-006_zyvox_lbl.pdf	6/25/2004
AP	2/10/2005	SLR	11110	007	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21130s007,21131s008,21132s007ltr.pdf	2/11/2005
AP	5/12/2005	SLR	11615	008	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf	5/17/2005
AP	5/12/2005	SLR	11643	008	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf	5/17/2005
AP	5/12/2005	SLR	11616	009	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s008,009,021131s009,010,021132s008,009ltr.pdf	5/17/2005
AP	5/12/2005	SLR	11644	009	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021130s008,009,021131s009,010,021132s008,009lbl.pdf	5/17/2005
AP	11/2/2005	SLR	13040	010	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021130s010,021131s011,021132s010ltr.pdf	11/8/2005
AP	4/26/2007	SLR	16346	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021130s012,021131s012,021132s012lbl.pdf	5/1/2007
AP	4/26/2007	SLR	16374	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021130s012,021131s012,021132s012ltr.pdf	5/1/2007
AP	4/26/2007	SLR	39772	012	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021130Orig1s012.pdf	7/7/2014
AP	3/26/2007	SCM
AP	3/21/2007	SCS
AP	6/8/2007	SCM
AP	6/20/2008	SLR	20061	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf	6/24/2008
AP	6/20/2008	SLR	20083	016	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021130s016,021131s013,021132s014lbl.pdf	6/26/2008
AP	6/20/2008	SLR	20062	017	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021130s016,s017,021131s013,s014,021132s014,s015ltr.pdf	6/24/2008
AP	9/18/2007	SCM
AP	2/19/2008	SCM
AP	12/8/2009	SLR	24280	020	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021130s020,021131s017,021132s018lbl.pdf	12/11/2009
AP	12/8/2009	SLR	24628	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021130s020,021131s017,021132s018ltr.pdf	1/26/2010
AP	7/16/2010	SLR	25978	022	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021130s022lbl.pdf	7/19/2010
AP	7/16/2010	SLR	26005	022	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021131s020,s021132s021,021130s022ltr.pdf	7/23/2010
AP	5/3/2013	SLR	35977	023	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf	5/7/2013
AP	5/3/2013	SLR	35996	023	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf	5/9/2013
AP	5/3/2013	SLR	35978	024	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021130Orig1s023,s024,021131Origs021,s022,021132Orig1s022,s023ltr.pdf	5/7/2013
AP	5/3/2013	SLR	35997	024	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021130s023s024,021131s021s022,021132s022s023lbl.pdf	5/9/2013
AP	2/13/2012	SLR	31789	028	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021130s028lbl.pdf	2/14/2012
AP	2/13/2012	SLR	31794	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021130s028,021131s024,021132s027ltr.pdf	2/15/2012
AP	1/24/2014	SLR	38369	032	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021130s032,021131s026,021132s031lbl.pdf	1/27/2014
AP	1/24/2014	SLR	38374	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021130Orig1s032,021131Orig1s026,021132Orig1s031ltr.pdf	1/28/2014
AP	7/28/2014	SCM
AP	6/5/2015	SLR	43015	035	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021130s030,021131s029,021132s034lbl.pdf	6/10/2015
AP	6/5/2015	SLR	43016	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021130Orig1s035,021131Orig1s029,021132Orig1s034ltr.pdf	6/10/2015

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