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Back to FDA Applications sponsored by BAYER PHARMS
FDA Drug Application 020740 by BAYER PHARMS
Application Number
020740
Application Type
New Drug Application
Sponsor Applicant
BAYER PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
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
6/26/1997
N
24879
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020740_baycol_toc.cfm
3/2/2010
AP
0
8/20/1998
SCS
AP
0
5/24/1999
SE2
3846
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20740s02ltr.pdf
5/24/1999
AP
0
5/24/1999
SE2
3847
002
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-740S002_Baycol.cfm
11/29/2001
AP
0
1/4/1999
SLR
3848
003
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-740S003_Baycol.pdf
11/29/2001
AP
0
7/13/1999
SCS
AP
0
8/23/1999
SCE
AP
0
3/30/2001
SLR
1392
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20740S6ltr.pdf
3/30/2001
AP
0
3/30/2001
SLR
1393
006
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S6lbl.pdf
3/30/2001
AP
0
3/30/2001
SLR
3849
006
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S006_Baycol.pdf
12/3/2001
AP
0
12/10/1999
SCS
17922
007
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020740s007.pdf
9/24/2007
AP
0
7/21/2000
SE2
3850
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20740S8,13LTR.PDF
7/23/2000
AP
0
7/21/2000
SE2
3851
008
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol.cfm
11/29/2001
AP
0
7/21/2000
SE2
4534
008
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf
7/21/2000
AP
0
12/22/1999
SCS
17921
010
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020740_S010_BAYCOL.pdf
9/24/2007
AP
0
7/3/2000
SCM
17920
012
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020740_S012_BAYCOL.pdf
9/24/2007
AP
0
7/21/2000
SE1
3852
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20740S8,13LTR.PDF
7/23/2000
AP
0
7/21/2000
SE1
3853
013
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol.cfm
11/29/2001
AP
0
7/21/2000
SE1
4535
013
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf
7/21/2000
AP
0
11/6/2000
SLR
3854
014
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S014_Baycol.pdf
12/3/2001
AP
0
1/23/2001
SCE
19160
016
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020740_S016_BAYCOL_TABLETS.pdf
2/19/2008
AP
0
2/27/2001
SCM
AP
0
5/10/2001
SCS
3855
018
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S018_Baycol.pdf
12/3/2001
AP
0
5/10/2001
SCS
5415
018
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S18lbl.pdf
4/22/2003
AP
0
5/21/2001
SLR
4434
019
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S019_Baycol.pdf
12/3/2001
AP
0
5/21/2001
SLR
5430
019
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S19lbl.pdf
4/23/2002
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