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Back to FDA Applications sponsored by NOVARTIS
FDA Drug Application 020539 by NOVARTIS
Application Number
020539
Application Type
New Drug Application
Sponsor Applicant
NOVARTIS
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
5/10/1996
N
2664
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20539S10ltr.pdf
5/3/2001
AP
0
12/6/1996
SCS
AP
0
10/4/1996
SCM
AP
0
1/5/1999
SE8
AP
0
4/21/1999
SCP
AP
0
2/1/2000
SCM
AP
0
4/30/2001
SCS
AP
0
4/13/2001
SLR
1624
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20539S10ltr.pdf
4/13/2001
AP
0
12/27/2001
SCM
AP
0
1/21/2004
SLR
7644
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20539slr012ltr.pdf
2/2/2004
AP
0
1/21/2004
SLR
7659
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20539slr012_lamisil_lbl.pdf
2/3/2004
AP
0
12/2/2010
SLR
27163
017
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020539s017lbl.pdf
12/4/2010
AP
0
12/2/2010
SLR
27195
017
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020539s017ltr.pdf
12/6/2010
AP
0
3/30/2011
SLR
28408
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020539s018ltr.pdf
3/31/2011
AP
0
3/30/2011
SLR
28429
018
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s018lbl.pdf
4/1/2011
AP
0
11/4/2011
SLR
30537
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020539s020ltr.pdf
11/8/2011
AP
0
11/4/2011
SLR
32166
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s020lbl.pdf
3/22/2012
AP
0
4/23/2012
SLR
32542
021
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020539s021ltr.pdf
4/27/2012
AP
0
4/23/2012
SLR
32596
021
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020539s021lbl.pdf
5/2/2012
AP
0
6/17/2013
SLR
36308
023
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s023lbl.pdf
6/17/2013
AP
0
6/17/2013
SLR
36339
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020539Orig1s023ltr.pdf
6/18/2013
AP
0
10/23/2013
SLR
37559
024
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020539Orig1s024ltr.pdf
10/25/2013
AP
0
10/23/2013
SLR
37585
024
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s024lbl.pdf
10/25/2013
AP
0
2/12/2016
SCM
AP
0
8/23/2016
SLR
46883
026
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020539Orig1s026ltr.pdf
8/25/2016
AP
0
8/23/2016
SLR
47181
026
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020539s026lbl.pdf
9/28/2016
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