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Back to FDA Applications sponsored by BAYER HLTHCARE
FDA Drug Application 018714 by BAYER HLTHCARE
Application Number
018714
Application Type
New Drug Application
Sponsor Applicant
BAYER HLTHCARE
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
12/29/1982
N
AP
0
5/11/1983
SLR
AP
0
8/20/1985
SLR
AP
0
11/9/1988
SLR
AP
0
8/9/1988
SCS
AP
0
8/9/1988
SCS
AP
0
11/7/1989
SCS
AP
0
7/14/2004
SLR
9797
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18714s008,009ltr.pdf
7/21/2004
AP
0
7/14/2004
SLR
9799
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf
7/21/2004
AP
0
7/14/2004
S
9796
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18714s008,009ltr.pdf
7/21/2004
AP
0
7/14/2004
S
9800
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf
7/21/2004
AP
0
8/16/2010
SLR
26230
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018714s012lbl.pdf
8/1/2010
AP
0
8/16/2010
SLR
26267
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018714s012ltr.pdf
8/20/2010
AP
0
2/25/2014
SLR
38608
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018714Orig1s013ltr.pdf
2/27/2014
AP
0
2/25/2014
SLR
38673
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018714s013lbl.pdf
3/5/2014
AP
0
9/18/2014
SCM
AP
0
11/20/2014
SCM
Back to FDA Applications sponsored by BAYER HLTHCARE