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Back to FDA Applications sponsored by AMGEN
FDA Drug Application 103353 by AMGEN
Application Number
103353
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
2/20/1991
N
30847
0000
http://www.accessdata.fda.gov/drugsatfda_docs/bla/pre96/103353Orig1s000.pdf
12/2/2011
AP
0
4/2/1998
S
8052
1036
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/filgamg040298L.htm
3/25/2004
AP
0
4/2/1998
S
8053
1036
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/filgamg040298lb.pdf
3/25/2004
AP
0
4/2/1998
S
8054
1036
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080686.htm
3/25/2004
AP
0
5/29/2002
S
8050
5001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/filgamg052902L.pdf
3/25/2004
AP
0
5/29/2002
S
8051
5001
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/filgamg052902LB.pdf
3/25/2004
AP
0
5/29/2002
S
10260
5001
Physician Package Insert Part 1
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/filgamg052902PLBp1.pdf
9/22/2004
AP
0
5/29/2002
S
10261
5001
Physician Package Insert Part 2
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/filgamg052902PLBp2.pdf
9/22/2004
AP
0
5/29/2002
S
10262
5001
Physician Package Insert 3
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/filgamg052902PLBp3.pdf
9/22/2004
AP
0
12/17/2004
S
11016
5059
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103353_5059ltr.pdf
1/26/2005
AP
0
12/17/2004
S
11040
5059
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103353_5059lbl.pdf
1/26/2005
AP
0
10/25/2006
S
15334
5086
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103353s5086LTR.pdf
11/9/2006
AP
0
10/25/2006
S
15337
5086
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103353s5086LBL.pdf
11/9/2006
AP
0
3/2/2010
S
25001
5127
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103353s5127ltr.pdf
3/8/2010
AP
0
3/2/2010
S
25030
5127
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103353_5127lbl.pdf
3/11/2010
AP
0
5/25/2012
S
32770
5147
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103353s5147ltr.pdf
5/29/2012
AP
0
5/25/2012
S
32776
5147
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103353s5147lbl.pdf
5/29/2012
AP
0
9/13/2013
SLR
37109
5157
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103353s5157lbl.pdf
9/17/2013
AP
0
9/13/2013
SLR
37141
5157
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103353Orig1s5157ltr.pdf
9/17/2013
AP
0
3/30/2015
SE8
42407
5183
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103353Orig1s5183ltr.pdf
4/3/2015
AP
0
2/6/2015
SLR
41800
5184
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5184lbl.pdf
2/6/2015
AP
0
2/6/2015
SLR
41801
5184
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103353Orig1s5184ltr.pdf
2/6/2015
AP
0
7/30/2015
SLR
43550
5186
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103353Orig1s5186ltr.pdf
7/31/2015
AP
0
7/30/2015
SLR
43561
5186
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5186lbl.pdf
8/4/2015
AP
0
6/29/2016
S
46445
5188
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103353Orig1s5188ltr.pdf
6/30/2016
AP
0
6/29/2016
S
46598
5188
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103353s5188.pdf
7/22/2016
Back to FDA Applications sponsored by AMGEN