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Back to FDA Applications sponsored by ORION PHARMA
FDA Drug Application 020796 by ORION PHARMA
Application Number
020796
Application Type
New Drug Application
Sponsor Applicant
ORION PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
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
10/19/1999
N
268
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20796LTR.PDF
12/30/1999
AP
0
10/19/1999
N
269
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20796LBL.PDF
12/30/1999
AP
0
10/19/1999
N
2561
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20796_Comtan.cfm
12/30/1999
AP
0
8/14/2001
SCS
AP
0
1/10/2002
SCM
AP
0
1/17/2002
SCP
AP
0
4/18/2002
SCP
AP
0
2/2/2009
SLR
21727
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020796s012,020796s013ltr.pdf
2/3/2009
AP
0
2/2/2009
SLR
21762
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf
2/4/2009
AP
0
1/30/2009
SLR
21728
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020796s012,020796s013ltr.pdf
2/3/2009
AP
0
1/30/2009
SLR
21763
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf
2/4/2009
AP
0
10/11/2010
SLR
26617
015
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020796s015lbl.pdf
10/11/2010
AP
0
10/11/2010
SLR
26654
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020796s015,021485s020ltr.pdf
10/13/2010
AP
0
6/13/2014
SLR
39548
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020796Orig1s016ltr.pdf
6/17/2014
AP
0
6/13/2014
SLR
39565
016
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020796s016lbl.pdf
6/17/2014
AP
0
1/16/2014
SCM
AP
0
10/11/2013
SCM
AP
0
1/16/2015
SLR
41647
024
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020796Orig1s024ltr.pdf
1/20/2015
AP
0
1/16/2015
SLR
41653
024
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020796s024lbl.pdf
1/20/2015
AP
0
10/16/2015
SCM
AP
0
2/22/2016
SLR
45252
026
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020796Orig1s026,021485Orig1s033ltr.pdf
2/24/2016
AP
0
2/22/2016
SLR
45293
026
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020796s026lbl.pdf
2/26/2016
AP
0
10/5/2016
SCM
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