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Back to FDA Applications sponsored by SPECTRUM PHARMS
FDA Drug Application 125019 by SPECTRUM PHARMS
Application Number
125019
Application Type
Biologic License Application
Sponsor Applicant
SPECTRUM PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
Therapeutic Potential
Orphan Code
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
2/19/2002
N
8180
0000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ibriide021902L.htm
3/30/2004
AP
0
2/19/2002
N
8181
0000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ibriide021902LB.pdf
3/30/2004
AP
0
2/19/2002
N
13229
0000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125019_0000_ZevalinTOC.cfm
12/8/2005
AP
0
10/2/2004
S
11022
0058
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125019_0058ltr.pdf
1/26/2005
AP
0
10/2/2004
S
11045
0058
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0058lbl.pdf
1/26/2005
AP
0
10/29/2004
S
11023
0070
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125019_0070ltr.pdf
1/26/2005
AP
0
10/29/2004
S
11042
0070
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0070lbl.pdf
1/26/2005
AP
0
7/27/2005
S
12562
0088
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125019_0088ltr.pdf
8/8/2005
AP
0
7/27/2005
S
12574
0088
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0088lbl.pdf
8/8/2005
AP
0
9/13/2005
S
12796
0092
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125019_0092ltr.pdf
9/15/2005
AP
0
9/13/2005
S
12797
0092
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0092lbl.pdf
9/15/2005
AP
0
11/2/2007
S
18356
0132
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125019s132ltr.pdf
11/8/2007
AP
0
11/2/2007
S
18415
0132
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125019s132lbl.pdf
11/13/2007
AP
0
3/25/2008
S
19547
0135
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125019s135lbl.pdf
3/27/2008
AP
0
3/25/2008
S
19551
0135
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125019s0135ltr.pdf
3/28/2008
AP
0
9/3/2009
S
23283
0156
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125019s0156ltr.pdf
9/10/2009
AP
0
9/3/2009
S
23410
0156
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125019s0156.pdf
9/18/2009
AP
0
11/18/2011
S
30815
0194
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125019s0194lbl.pdf
11/30/2011
AP
0
11/18/2011
S
30837
0194
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125019s0194ltr.pdf
12/2/2011
AP
0
8/30/2013
SLR
36951
210
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125019Orig1s210,s213ltr.pdf
9/5/2013
AP
0
8/30/2013
SLR
37025
210
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf
9/9/2013
AP
0
8/30/2013
SLR
36952
213
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125019Orig1s210,s213ltr.pdf
9/5/2013
AP
0
8/30/2013
SLR
37026
213
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf
9/9/2013
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