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Back to FDA Applications sponsored by CONCORDIA PHARMS INC
FDA Drug Application 021959 by CONCORDIA PHARMS INC
Application Number
021959
Application Type
New Drug Application
Sponsor Applicant
CONCORDIA PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New formulation
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
6/1/2006
N
14220
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021959lbl.pdf
6/2/2006
AP
0
6/1/2006
N
20167
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021959TOC.cfm
7/8/2008
AP
0
4/27/2009
SCM
22425
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021959s003ltr.pdf
5/5/2009
AP
0
4/27/2009
SCM
22495
003
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021959s003lbl.pdf
5/11/2009
AP
0
7/28/2010
SLR
26041
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021959s004ltr.pdf
7/30/2010
AP
0
7/28/2010
SLR
26063
004
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021959s004lbl.pdf
7/31/2010
AP
0
4/8/2016
SCM
AP
0
7/28/2016
SCM
Back to FDA Applications sponsored by CONCORDIA PHARMS INC