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Back to FDA Applications sponsored by AVEVA
FDA Drug Application 019983 by AVEVA
Application Number
019983
Application Type
New Drug Application
Sponsor Applicant
AVEVA
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
1/28/1992
N
AP
0
5/13/1992
SCM
AP
0
4/1/1993
SCM
AP
0
2/2/1993
SCS
AP
0
2/2/1993
SCS
AP
0
1/26/1996
SLR
AP
0
12/23/1998
SCM
1042
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19983s12ltr.pdf
12/23/1998
AP
0
12/23/1998
SCM
1043
011
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19983s012_Prostep.cfm
12/23/1998
AP
0
12/23/1998
SE6
1045
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19983s12ltr.pdf
12/23/1998
AP
0
12/23/1998
SE6
1046
012
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19983s012_Prostep.cfm
12/23/1998
AP
0
4/4/2000
SCS
AP
0
5/7/2001
SCS
AP
0
1/18/2002
SLR
4061
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19983s16ltr.pdf
1/18/2002
AP
0
1/18/2002
SLR
4062
016
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19983s16lbl.pdf
1/18/2002
AP
0
10/4/2002
SLR
4060
017
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19983slr017ltr.pdf
10/4/2002
Back to FDA Applications sponsored by AVEVA