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Back to FDA Applications sponsored by AMGEN
FDA Drug Application 103951 by AMGEN
Application Number
103951
Application Type
Biologic License Application
Sponsor Applicant
AMGEN
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
9/17/2001
N
7573
0000
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080442.htm
1/21/2004
AP
0
9/17/2001
N
7574
0000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/darbamg091701L.htm
1/21/2004
AP
0
9/17/2001
N
7575
0000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/darbamg091701LB.htm
1/21/2004
AP
0
9/17/2001
N
24741
0000
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085918.pdf
2/5/2010
AP
0
9/17/2001
N
24779
0000
REMS
http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=6
2/16/2010
AP
0
7/19/2002
S
7885
5001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/darbamg071902L.htm
3/11/2004
AP
0
7/19/2002
S
7886
5001
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/darbamg071902LB.pdf
3/11/2004
AP
0
7/19/2002
S
10271
5001
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/darbamg071902LB2.pdf
9/22/2004
AP
0
7/19/2002
S
30857
5001
http://www.accessdata.fda.gov/drugsatfda_docs/bla/2002/103951Orig1s5001.pdf
12/2/2011
AP
0
12/16/2004
S
11020
5069
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103951_5069ltr.pdf
1/26/2005
AP
0
12/16/2004
S
11035
5069
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103951_5069lbl.pdf
1/26/2005
AP
0
12/15/2005
S
13597
5088
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103951s5088lbl.pdf
2/8/2006
AP
0
12/15/2005
S
13616
5088
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103951s5088ltr.pdf
2/8/2006
AP
0
10/26/2005
S
13293
5096
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103951s5096ltr.pdf
12/16/2005
AP
0
10/26/2005
S
13297
5096
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103951s5096lbl.pdf
12/16/2005
AP
0
3/23/2006
S
13868
5097
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103951s5097ltr.pdf
4/5/2006
AP
0
3/23/2006
S
13869
5097
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103951s5097LBL.pdf
4/5/2006
AP
0
5/5/2008
S
AP
0
4/10/2007
S
16247
5135
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5135ltr .pdf
4/20/2007
AP
0
4/10/2007
S
16281
5135
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5135LBL.pdf
4/20/2007
AP
0
3/9/2007
S
16005
5139
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5139lbl.pdf
3/9/2007
AP
0
3/9/2007
S
16025
5139
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5139ltr.pdf
3/15/2007
AP
0
11/8/2007
S
18345
5164
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5164ltr.pdf
11/8/2007
AP
0
11/8/2007
S
18346
5164
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5164lbl.pdf
11/8/2007
AP
0
11/8/2007
S
18350
5164
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5164ppi.pdf
11/8/2007
AP
0
12/17/2007
S
18966
5169
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103951s5169lbl.pdf
1/30/2008
AP
0
12/17/2007
S
18990
5169
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103951s5169ltr.pdf
1/31/2008
AP
0
3/7/2008
S
19417
5170
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5170lbl.pdf
3/11/2008
AP
0
3/7/2008
S
19422
5170
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5170ppi.pdf
3/12/2008
AP
0
3/7/2008
S
19434
5170
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103951s5170ltr.pdf
3/13/2008
AP
0
6/24/2011
S
29242
5173
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951Orig1s5173,103951Orig1s5258ltr.pdf
6/24/2011
AP
0
6/24/2011
S
29244
5173
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173_103951Orig1s5258lbl.pdf
6/24/2011
AP
0
6/24/2011
S
32764
5173
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173SumR.pdf
5/25/2012
AP
0
6/24/2011
S
33197
5173
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/103951_aranesp_toc.cfm
7/16/2012
AP
0
11/19/2008
S
21292
5195
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5195PI.pdf
11/26/2008
AP
0
11/19/2008
S
28620
5195
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103951s5195ltr.pdf
4/28/2011
AP
0
2/16/2010
S
24773
5197
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103951s5197ltr.pdf
2/16/2010
AP
0
2/16/2010
S
24774
5197
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103951s5197lbl.pdf
2/16/2010
AP
0
10/13/2009
S
24720
5211
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103951s5211Lbl.pdf
2/4/2010
AP
0
10/13/2009
S
24732
5211
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103951s5211ltr.pdf
2/5/2010
AP
0
1/11/2010
S
24719
5223
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103951s5223LBL.pdf
2/4/2010
AP
0
6/24/2011
S
29248
5248
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951s5248,103234s5256ltr.pdf
6/24/2011
AP
0
6/24/2011
S
29243
5258
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103951Orig1s5173,103951Orig1s5258ltr.pdf
6/24/2011
AP
0
6/24/2011
S
29245
5258
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103951Orig1s5173_103951Orig1s5258lbl.pdf
6/24/2011
AP
0
5/31/2012
S
32793
5285
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103951s5285ltr.pdf
6/4/2012
AP
0
5/31/2012
S
32819
5285
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103951s5285lbl.pdf
6/6/2012
AP
0
12/31/2013
SLR
38208
5325
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103951Orig1s5325ltr.pdf
1/2/2014
AP
0
12/31/2013
SLR
38221
5325
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103951s5325lbl.pdf
1/7/2014
AP
0
3/27/2013
SLR
35563
5337
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103951Orig1s5337ltr.pdf
3/29/2013
AP
0
12/31/2013
SLR
38209
5349
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103951Orig1s5349ltr.pdf
1/2/2014
AP
0
12/31/2013
SLR
38223
5349
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103951s5349lbl.pdf
1/7/2014
AP
0
4/17/2014
SLR
39099
5353
http://deleted per r. berger
4/18/2014
AP
0
7/23/2015
SE8
43472
5363
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103951Orig1s5363ltr.pdf
7/24/2015
AP
0
7/23/2015
SE8
43486
5363
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103951s5363lbl.pdf
7/24/2015
AP
0
4/27/2016
SLR
45792
5370
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103951Orig1s5370ltr.pdf
4/28/2016
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