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Back to FDA Applications sponsored by DUCHESNAY
FDA Drug Application 021876 by DUCHESNAY
Application Number
021876
Application Type
New Drug Application
Sponsor Applicant
DUCHESNAY
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New manufacturer
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
4/8/2013
N
35669
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021876Orig1s000ltr.pdf
4/10/2013
AP
0
4/8/2013
N
35727
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s000lbl.pdf
4/16/2013
AP
0
4/8/2013
N
38906
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021876Orig1s000TOC.cfm
3/25/2014
AP
0
4/8/2013
N
38907
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021876Orig1s000SumR.pdf
3/25/2014
AP
0
1/29/2014
SCM
AP
0
9/30/2013
SCM
37277
002
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021876s002lbl.pdf
9/30/2013
AP
0
3/28/2014
SCM
AP
0
7/30/2014
SCM
AP
0
11/24/2014
SCM
AP
0
12/16/2014
SLR
41285
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021876Orig1s006ltr.pdf
12/17/2014
AP
0
6/23/2015
SCM
AP
0
9/10/2015
SCM
AP
0
3/10/2016
SCM
Back to FDA Applications sponsored by DUCHESNAY