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Back to FDA Applications sponsored by EMD SERONO
FDA Drug Application 019764 by EMD SERONO
Application Number
019764
Application Type
New Drug Application
Sponsor Applicant
EMD SERONO
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New manufacturer
Therapeutic Potential
Standard
Orphan Code
V
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
10/8/1996
N
AP
0
12/9/1996
SLR
AP
0
1/21/1998
SCM
AP
0
8/29/2000
SCS
AP
0
7/9/1998
SCM
AP
0
2/11/1999
SCM
AP
0
4/4/2000
SLR
AP
0
3/28/2000
SCM
AP
0
6/7/2000
SCM
AP
0
7/26/2000
SLR
AP
0
4/11/2000
SCM
AP
0
7/19/2000
SCS
21608
011
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019764_s011_SAIZEN INJECTION.pdf
1/12/2009
AP
0
8/17/2000
SCS
AP
0
5/3/2001
SCM
AP
0
7/19/2001
SCM
AP
0
9/6/2002
SCS
AP
0
12/3/2001
SCS
AP
0
12/20/2002
SCM
AP
0
12/31/2002
SCM
AP
0
10/17/2002
SCS
AP
2
11/1/2004
SE1
10580
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19764s020ltr.pdf
11/15/2004
AP
2
11/1/2004
SE1
10581
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764s020lbl.pdf
11/15/2004
AP
0
7/1/2003
SLR
6089
023
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19764slr023_saizen_lbl.pdf
7/8/2003
AP
0
7/1/2003
SLR
6095
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19764slr023ltr.pdf
7/8/2003
AP
0
7/9/2004
SCP
9735
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19764scp,20604scp030ltr.pdf
7/14/2004
AP
0
7/9/2004
SCP
9738
025
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764scp,20604scp030_serostim_lbl.pdf
7/14/2004
AP
0
1/16/2007
SCS
15686
030
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s030lbl.pdf
1/18/2007
AP
0
1/16/2007
SCS
15708
030
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s030ltr.pdf
1/25/2007
AP
0
3/5/2007
SLR
15982
034
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s034lbl.pdf
3/7/2007
AP
0
3/5/2007
SLR
16033
034
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s034ltr.pdf
3/15/2007
AP
0
10/31/2007
SCP
18309
035
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s035lbl.pdf
11/7/2007
AP
0
10/31/2007
SCP
18372
035
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s035ltr.pdf
11/8/2007
AP
0
8/22/2007
SLR
17703
037
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s037lbl.pdf
8/23/2007
AP
0
8/22/2007
SLR
17723
037
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s037ltr.pdf
8/27/2007
AP
0
8/27/2007
SLR
17725
039
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s039lbl.pdf
8/30/2007
AP
0
8/27/2007
SLR
17729
039
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s039ltr.pdf
8/30/2007
AP
0
4/3/2012
SLR
32358
049
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020604s049,019764s049ltr.pdf
4/5/2012
AP
0
4/3/2012
SLR
32366
049
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019764s049lbl.pdf
4/6/2012
AP
0
1/11/2013
SCM
AP
0
1/11/2013
SCM
AP
0
1/18/2013
SCM
AP
0
1/19/2013
SCM
AP
0
1/19/2013
SCM
AP
0
1/19/2013
SCM
AP
0
11/13/2013
SCM
AP
0
2/7/2013
SCM
AP
0
2/8/2013
SCM
AP
0
6/11/2015
SCM
AP
0
2/13/2013
SCM
AP
0
1/31/2013
SCM
AP
0
2/15/2013
SCM
AP
0
2/15/2013
SCM
AP
0
2/20/2013
SCM
AP
0
4/5/2013
SCM
AP
0
12/12/2013
SCM
AP
0
11/18/2013
SCM
AP
0
6/16/2014
SLR
39553
072
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019764s072lbl.pdf
6/17/2014
AP
0
6/16/2014
SLR
39579
072
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019764Orig1s072ltr.pdf
6/18/2014
AP
0
9/30/2014
SCM
AP
0
8/11/2014
SCM
AP
0
2/16/2015
SCM
AP
0
3/3/2015
SCM
AP
0
6/12/2015
SCM
AP
0
4/21/2016
SCM
AP
0
9/7/2016
SCM
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