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FDA Drug Application 021700 by SB PHARMCO

Application Number	021700
Application Type	New Drug Application
Sponsor Applicant	SB PHARMCO
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New combination
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	11/23/2005	N	13136	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021700lbl.pdf	11/30/2005
AP	11/23/2005	N	13173	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021700ltr.pdf	11/30/2005
AP	11/23/2005	N	16869	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021700s000TOC.cfm	7/2/2007
AP	11/23/2005	N	19248	000	http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm	2/21/2008
AP	11/23/2005	N	23885	000	http://www.fda.gov/downloads/Drugs/DrugSafety/UCM143421.pdf	11/16/2009
AP	6/15/2006	SLR	14326	002	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s002s004lbl.pdf	6/20/2006
AP	6/15/2006	SLR	14330	002	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s002,217s004LTR.pdf	6/20/2006
AP	10/24/2006	SE1	15203	003	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s003lbl.pdf	10/25/2006
AP	10/24/2006	SE1	15250	003	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s003ltr.pdf	10/26/2006
AP	6/15/2006	SLR	14327	004	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s002s004lbl.pdf	6/20/2006
AP	6/15/2006	SLR	14331	004	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s002,217s004LTR.pdf	6/20/2006
AP	3/30/2007	SCM	16175	005	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s005ltr.pdf	4/9/2007
AP	9/20/2007	SLR	17977	006	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s006ltr.pdf	9/25/2007
AP	8/21/2007	SLR	17670	007	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021700s007lbl.pdf	8/22/2007
AP	8/21/2007	SLR	17680	007	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s007ltr.pdf	8/22/2007
AP	12/2/2008	SLR	21320	008	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021700s008ltr.pdf	12/4/2008
AP	12/2/2008	SLR	21326	008	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021700s008lbl.pdf	12/4/2008
AP	11/29/2009	SLR	24242	009	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021700s009lbl.pdf	12/10/2009
AP	2/3/2011	SLR	27685	010	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s038,021410s026,021700s010ltr.pdf	2/3/2011
AP	2/3/2011	SLR	27703	010	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf	2/4/2011
AP	5/18/2011	SLR	28853	011	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s011lbl.pdf	5/17/2011
AP	5/18/2011	SLR	28854	011	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s011MedG.pdf	5/17/2011
AP	5/18/2011	SLR	28915	011	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s039,021410s027,021700s011ltr.pdf	5/24/2011
AP	11/13/2011	SLR	30626	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s012lbl.pdf	11/16/2011
AP	11/13/2011	SLR	30627	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s012MedG.pdf	11/16/2011
AP	11/13/2011	SLR	30693	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s040,021410s029,021700s012ltr.pdf	11/21/2011
AP	5/30/2012	SLR	32788	013	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021071s041,021410s030,021700s013ltr.pdf	6/4/2012
AP	5/30/2012	SLR	32829	013	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021700s013lbl.pdf	6/6/2012
AP	1/25/2013	S	35004	015	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s044,021410Orig1s032,021700Orig1s015ltr.pdf	1/30/2013
AP	9/16/2013	SLR	37156	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s045,021410Orig1s034,021700Orig1s016ltr.pdf	9/19/2013
AP	5/7/2014	SLR	39247	018	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf	5/8/2014
AP	5/7/2014	SLR	39279	018	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf	5/12/2014
AP	5/7/2014	SLR	39248	019	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf	5/8/2014
AP	5/7/2014	SLR	39280	019	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf	5/12/2014
AP	5/7/2014	SLR	39249	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf	5/8/2014
AP	5/7/2014	SLR	39281	020	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf	5/12/2014
AP	3/16/2015	SLR	42168	021	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021700Orig1s021ltr.pdf	3/17/2015
AP	3/16/2015	SLR	42198	021	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021700s021lbl.pdf	3/19/2015
AP	12/16/2015	S	44794	022	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021071Orig1s050,021410Orig1s039,021700Orig1s022ltr.pdf	12/17/2015

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