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Back to FDA Applications sponsored by SETON PHARM
FDA Drug Application 019157 by SETON PHARM
Application Number
019157
Application Type
New Drug Application
Sponsor Applicant
SETON PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New formulation
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
5/28/1986
N
16211
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019157_PEDIAPRED_ORIGINAL_AP.pdf
4/11/2007
AP
0
8/14/1986
SCP
AP
0
2/2/1989
SCS
AP
0
10/31/1988
SCM
AP
0
10/27/1989
SCM
AP
0
11/8/1993
SCS
AP
0
11/22/1993
SLR
AP
0
5/10/1995
SCM
AP
0
12/17/1998
SLR
54
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf
12/17/1998
AP
0
12/17/1998
SLR
57
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf
12/17/1998
AP
0
12/17/1998
SLR
157
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf
12/17/1998
AP
0
5/29/1997
SCS
AP
0
12/17/1998
SE5
408
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf
12/17/1998
AP
0
1/21/1998
SLR
6635
016
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19-157S016.pdf
9/11/2003
AP
0
1/3/2002
SCM
AP
0
12/3/2004
SLR
10774
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19157s018ltr.pdf
12/8/2004
AP
0
12/3/2004
SLR
10775
018
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19157s018lbl.pdf
12/8/2004
AP
0
12/3/2004
SLR
14061
018
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019157_018_PrediapredTOC.cfm
5/8/2006
AP
0
10/8/2013
SLR
37401
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019157Orig1s020ltr.pdf
10/10/2013
AP
0
10/8/2013
SLR
37447
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019157s020lbl.pdf
10/17/2013
Back to FDA Applications sponsored by SETON PHARM