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Back to FDA Applications sponsored by ORION PHARMA
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 Title
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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