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FDA Drug Application 021485 by ORION PHARMA

Application Number	021485
Application Type	New Drug Application
Sponsor Applicant	ORION PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New combination
Therapeutic Potential	Standard
Orphan Code

Action Type	Duplicate Counter	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	0	6/11/2003	N	5977	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21485ltr.pdf	6/22/2003
AP	0	6/11/2003	N	5985	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21485_stalevo_lbl.pdf	6/22/2003
AP	0	6/11/2003	N	8033	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-485_Stalevo.cfm	3/24/2004
AP	0	6/11/2003	N	26147	000	http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm206513.htm	8/9/2010
AP	0	2/2/2009	SLR	21720	008	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).pdf	2/3/2009
AP	0	2/2/2009	SLR	21781	008	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf	2/4/2009
AP	0	2/2/2009	SLR	21957	008	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012(2)ltr.pdf	3/5/2009
AP	0	2/2/2009	SLR	22078	008	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf	3/23/2009
AP	1	3/3/2009	SLR	21720	008	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).pdf	2/3/2009
AP	1	3/3/2009	SLR	21781	008	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf	2/4/2009
AP	1	3/3/2009	SLR	21957	008	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012(2)ltr.pdf	3/5/2009
AP	1	3/3/2009	SLR	22078	008	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf	3/23/2009
AP	0	8/2/2007	SCF	17474	011	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021485s011lbl.pdf	8/3/2007
AP	0	8/2/2007	SCF	17568	011	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/0214855s011ltr.pdf	8/7/2007
AP	0	2/2/2009	SLR	21719	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).pdf	2/3/2009
AP	0	2/2/2009	SLR	21956	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012(2)ltr.pdf	3/5/2009
AP	0	2/2/2009	SLR	22079	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf	3/23/2009
AP	0	2/2/2009	SLR	22080	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf	2/4/2009
AP	1	3/3/2009	SLR	21719	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012ltr(corrected).pdf	2/3/2009
AP	1	3/3/2009	SLR	21956	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021485s008,s012(2)ltr.pdf	3/5/2009
AP	1	3/3/2009	SLR	22079	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf	3/23/2009
AP	1	3/3/2009	SLR	22080	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021485s008, s012lbl.pdf	2/4/2009
AP	0	8/29/2008	SCF	20727	016	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021485s016lbl.pdf	8/29/2008
AP	0	8/29/2008	SCF	20728	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021485s016ltr.pdf	9/3/2008
AP	0	9/26/2008	SLR	20908	017	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021485s017ltr.pdf	10/1/2008
AP	0	9/26/2008	SLR	20934	017	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021485s017lbl.pdf	10/3/2008
AP	0	10/11/2010	SLR	26616	020	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021485s20lbl.pdf	10/11/2010
AP	0	10/11/2010	SLR	26655	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020796s015,021485s020ltr.pdf	10/13/2010
AP	0	4/5/2013	SCM
AP	0	7/18/2014	SLR	39955	028	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021485s028s029lbl.pdf	7/23/2014
AP	0	7/18/2014	SLR	39985	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021485Orig1s028,s029ltr.pdf	7/24/2014
AP	0	7/18/2014	SLR	39956	029	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021485s028s029lbl.pdf	7/23/2014
AP	0	7/18/2014	SLR	39986	029	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021485Orig1s028,s029ltr.pdf	7/24/2014
AP	0	1/16/2014	SCM
AP	0	2/14/2014	SCM
AP	0	2/22/2016	SLR	45253	033	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020796Orig1s026,021485Orig1s033ltr.pdf	2/24/2016
AP	0	2/22/2016	SLR	45272	033	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021485s033lbl.pdf	2/25/2016
AP	0	1/29/2016	SCM
AP	0	2/18/2016	SCM	45249	035	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021485s033lbl.pdf	2/23/2016
AP	0	2/25/2016	SCM

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