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Back to FDA Applications sponsored by FRESENIUS KABI USA
FDA Drug Application 017029 by FRESENIUS KABI USA
Application Number
017029
Application Type
New Drug Application
Sponsor Applicant
FRESENIUS KABI USA
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
2/22/1972
N
AP
0
8/29/1975
SCS
AP
0
2/9/1976
SCS
AP
0
3/17/1976
SCS
AP
0
1/9/1976
SCF
AP
0
1/9/1976
SCS
AP
0
2/9/1976
SLR
AP
0
6/16/1976
SCM
AP
0
12/4/1977
SLR
AP
0
1/26/1977
SCF
AP
0
12/3/1976
SCF
AP
0
12/3/1976
SCS
AP
0
12/14/1977
SCS
AP
0
5/23/1978
SLR
AP
0
11/21/1978
SCS
AP
0
11/21/1978
SCS
AP
0
10/31/1979
SCM
AP
0
10/31/1979
SCS
AP
0
3/24/1981
SCM
AP
0
2/24/1981
SLR
AP
0
9/17/1982
SCS
AP
0
5/6/1982
SLR
AP
0
9/21/1982
SCM
AP
0
9/21/1982
SCM
AP
0
1/4/1983
SCE
AP
0
11/2/1983
SCE
AP
0
11/2/1983
SCF
AP
0
5/16/1985
SCF
AP
0
11/2/1983
SCF
AP
0
11/2/1983
SCF
AP
0
11/2/1983
SCF
AP
0
11/2/1983
SCF
AP
0
12/5/1985
SCP
AP
0
12/5/1985
SCP
AP
0
12/5/1985
SCP
AP
0
12/5/1985
SCP
AP
0
12/5/1985
SCP
AP
0
12/5/1985
SCP
AP
0
11/6/1984
SCP
AP
0
7/29/1985
SES
AP
0
9/22/1987
SCP
AP
0
9/22/1987
SCP
AP
0
4/7/1986
SLR
AP
0
4/28/1986
SCS
AP
0
6/26/1992
SLR
AP
0
12/1/1989
SCP
AP
0
2/16/1988
SCS
AP
0
9/22/1988
SLR
AP
0
6/8/1989
SCP
AP
0
8/6/1998
SCM
AP
0
8/6/1998
SCM
AP
0
8/25/1993
SLR
AP
0
7/26/1996
SCS
AP
0
10/27/1994
SCM
AP
0
5/17/1995
SCM
AP
0
8/6/1998
SCM
AP
0
6/24/1997
SCS
AP
0
11/4/1997
SCS
AP
0
3/8/2000
SCP
AP
0
12/13/1999
SCM
AP
0
3/22/2002
SLR
2211
099
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17029s099ltr.pdf
3/22/2002
AP
0
9/23/2008
SLR
20890
108
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017029s108ltr.pdf
9/26/2008
AP
0
9/23/2008
SLR
20940
108
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017029s108lbl.pdf
10/3/2008
AP
0
6/11/2010
SLR
25731
120
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017029s120,017651s048ltr.pdf
6/14/2010
AP
0
6/11/2010
SLR
25780
120
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf
6/24/2010
AP
0
6/24/2011
SLR
29389
128
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s128,017651s052ltr.pdf
7/5/2011
AP
0
12/23/2015
SCM
AP
0
12/23/2011
SLR
31262
131
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017029s131017651s055lbl.pdf
12/23/2011
AP
0
12/23/2011
SLR
31292
131
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s131,017651s055ltr.pdf
12/29/2011
AP
0
3/9/2015
SCM
AP
0
3/21/2014
SLR
38983
135
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017029Orig1s135,017651Orig1s059.pdf
4/7/2014
AP
0
9/24/2013
SCM
AP
0
7/21/2015
SCM
AP
0
6/9/2016
SCM
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