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Back to FDA Applications sponsored by RECORDATI RARE
FDA Drug Application 017105 by RECORDATI RARE
Application Number
017105
Application Type
New Drug Application
Sponsor Applicant
RECORDATI RARE
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
6/23/1972
N
AP
0
3/31/1975
SCS
AP
0
11/13/1975
SCS
AP
0
11/5/1975
SLR
AP
0
9/10/1975
SCS
AP
0
8/4/1976
SCS
AP
0
8/4/1976
SLR
AP
0
7/30/1976
SCS
AP
0
3/18/1977
SCS
AP
0
5/7/1976
SCF
AP
0
3/10/1980
SCM
AP
0
12/21/1976
SCM
AP
0
1/4/1977
SCM
AP
0
12/21/1976
SCM
AP
0
10/20/1977
SCF
AP
0
7/9/1979
SCS
AP
0
10/21/1977
SLR
AP
0
5/5/1978
SCF
AP
0
4/17/1978
SCF
AP
0
12/6/1978
SCP
AP
0
6/7/1979
SCS
AP
0
6/7/1979
SCS
AP
0
6/7/1979
SCM
AP
0
6/5/1979
SCF
AP
0
5/31/1979
SCS
AP
0
1/29/1981
SES
AP
0
12/12/1979
SLR
AP
0
7/14/1980
SLR
AP
0
9/8/1980
SCF
AP
0
10/28/1980
SCS
AP
0
2/27/1984
SCS
AP
0
6/16/1986
SCS
AP
0
8/26/1985
SCS
AP
0
8/29/1986
SCS
AP
0
11/14/1986
SCS
AP
0
1/8/1987
SCS
AP
0
8/13/1987
SCS
AP
0
2/7/2002
SLR
4021
059
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17105s59s62ltr.pdf
2/7/2002
AP
0
2/7/2002
SLR
17136
059
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017105_S059_TRANXENE_AP.pdf
7/9/2007
AP
0
11/5/1987
SCP
AP
0
2/7/2002
SLR
4022
062
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17105s59s62ltr.pdf
2/7/2002
AP
0
2/7/2002
SLR
17135
062
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017105_S062_TRANXENE_AP.pdf
7/9/2007
AP
0
11/8/1988
SCS
AP
0
11/5/1996
SCS
AP
0
8/4/1999
SCS
AP
0
5/8/1998
SCP
AP
0
8/28/2002
SCS
AP
0
3/13/2003
SLR
4508
070
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17105slr070ltr.pdf
3/26/2003
AP
0
3/13/2003
SLR
15226
070
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017105_S070_Tranxene_APPROVAL_PACKAGE.pdf
10/25/2006
AP
0
4/23/2009
SLR
22344
075
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017105s075lbl.pdf
4/28/2009
AP
0
4/23/2009
SLR
22356
075
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017105s075ltr.pdf
4/29/2009
AP
0
6/7/2010
SLR
25728
076
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017105s076lbl.pdf
6/14/2010
AP
0
6/7/2010
SLR
25733
076
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017105s076ltr.pdf
6/15/2010
AP
0
6/7/2010
SLR
25775
076
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017105s076MedGuide.pdf
6/24/2010
AP
0
7/19/2011
SLR
29567
077
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017105s077ltr.pdf
7/21/2011
AP
0
2/3/2015
SCM
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