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Back to FDA Applications sponsored by TURING PHARMS AG
FDA Drug Application 008578 by TURING PHARMS AG
Application Number
008578
Application Type
New Drug Application
Sponsor Applicant
TURING PHARMS AG
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
Therapeutic Potential
Priority
Orphan Code
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
1/23/1953
N
AP
0
2/20/1987
SPD
AP
0
10/17/1988
SLR
AP
0
4/8/1998
SLR
AP
0
3/25/1997
SLR
AP
0
4/8/1998
SLR
AP
0
10/10/2002
SLR
1641
015
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/8578s15lbl.pdf
10/10/2002
AP
0
10/10/2002
SLR
8881
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/8578slr015ltr.pdf
6/2/2004
AP
0
11/18/2003
SLR
6925
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08578slr016ltr.pdf
11/25/2003
AP
0
11/18/2003
SLR
7002
016
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08578slr016_daraprim_lbl.pdf
12/1/2003
Back to FDA Applications sponsored by TURING PHARMS AG