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Back to FDA Applications sponsored by VALEANT BERMUDA
FDA Drug Application 050756 by VALEANT BERMUDA
Application Number
050756
Application Type
New Drug Application
Sponsor Applicant
VALEANT BERMUDA
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New combination
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
12/21/2000
N
4422
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-756_Benzaclin.cfm
12/21/2000
AP
0
12/21/2000
N
4536
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-756_Benzaclin_Approv.pdf
12/21/2000
AP
0
12/21/2000
N
4537
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-756_Benzaclin_prntlbl.pdf
12/21/2000
AP
0
4/17/2001
SCM
AP
0
8/30/2001
SCS
AP
0
10/12/2001
SCS
AP
0
9/25/2001
SCM
AP
0
9/26/2001
SCM
AP
0
3/26/2002
SCM
AP
0
8/9/2002
SCP
4423
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50756scp007ltr.pdf
8/9/2002
AP
0
8/9/2002
SCP
4424
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50756s7lbl.pdf
8/9/2002
AP
0
6/27/2002
SCS
AP
0
8/28/2002
SCM
AP
0
4/28/2005
SLR
11555
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050756s016ltr.pdf
5/2/2005
AP
0
4/28/2005
SLR
11561
016
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050756s016lbl.pdf
5/2/2005
AP
0
5/23/2007
SLR
16637
026
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050756s026lbl.pdf
5/29/2007
AP
0
5/23/2007
SLR
16681
026
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050756s026ltr.pdf
6/4/2007
AP
0
4/20/2007
SCS
16293
027
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050756s027lbl.pdf
4/25/2007
AP
0
4/20/2007
SCS
16413
027
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050756s027ltr.pdf
5/1/2007
AP
0
6/12/2009
SLR
22765
034
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050756s034ltr.pdf
6/17/2009
AP
0
6/12/2009
SLR
22786
034
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050756s034lbl.pdf
6/22/2009
AP
0
6/17/2010
SLR
25759
037
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050756s037ltr.pdf
6/18/2010
AP
0
6/17/2010
SLR
25786
037
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050756s037lbl.pdf
6/24/2010
AP
0
3/2/2011
SCM
28124
040
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050756s040lbl.pdf
3/7/2011
AP
0
3/2/2011
SCM
28185
040
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050756s040ltr.pdf
3/8/2011
AP
0
9/22/2014
SCM
AP
0
12/5/2014
SCM
Back to FDA Applications sponsored by VALEANT BERMUDA