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Back to FDA Applications sponsored by NOVARTIS
FDA Drug Application 021985 by NOVARTIS
Application Number
021985
Application Type
New Drug Application
Sponsor Applicant
NOVARTIS
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
3/5/2007
N
15983
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021985lbl.pdf
3/7/2007
AP
0
3/5/2007
N
16031
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021985s000ltr.pdf
3/15/2007
AP
0
3/5/2007
N
16326
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021985s000TOC.cfm
4/30/2007
AP
0
3/5/2007
N
34446
000
http://www.fda.gov/Drugs/DrugSafety/ucm300889.htm
11/23/2012
AP
0
8/7/2007
SLR
17617
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021985s002ltr.pdf
8/14/2007
AP
0
2/15/2008
SLR
19239
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021985s004ltr.pdf
2/20/2008
AP
0
5/19/2008
SLR
19861
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021985s006ltr.pdf
5/21/2008
AP
0
11/10/2009
SLR
23907
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021985s008lbl.pdf
11/16/2009
AP
0
11/10/2009
SLR
24610
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021985s008ltr.pdf
1/25/2010
AP
0
8/4/2010
SLR
26197
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021985s012ltr.pdf
8/10/2010
AP
0
8/4/2010
SLR
26232
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021985s012lbl.pdf
8/4/2010
AP
0
2/10/2011
SLR
27818
014
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021985s014lbl.pdf
2/11/2011
AP
0
2/10/2011
SLR
27832
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021985s014ltr.pdf
2/14/2011
AP
0
10/12/2011
SLR
30332
019
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021985s019ltr.pdf
10/17/2011
AP
0
10/12/2011
SLR
30368
019
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021985s019lbl.pdf
10/20/2011
AP
0
1/26/2012
SLR
31590
021
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985s021ltr.pdf
1/31/2012
AP
0
1/26/2012
SLR
31614
021
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s021lbl.pdf
1/31/2012
AP
0
2/2/2012
SLR
31676
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985Orig1s022LBL.pdf
2/6/2012
AP
0
2/2/2012
SLR
31703
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985s022ltrC.pdf
2/7/2012
AP
0
4/16/2012
SLR
32453
023
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s023lbl.pdf
4/16/2012
AP
0
4/16/2012
SLR
32465
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985s023ltr.pdf
4/18/2012
AP
0
9/28/2012
SLR
33882
024
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021985s024lbl.pdf
10/1/2012
AP
0
9/28/2012
SLR
33917
024
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021985Orig1s024ltr.pdf
10/2/2012
AP
0
11/4/2013
SLR
37681
025
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021985s025lbl.pdf
11/4/2013
AP
0
11/4/2013
SLR
37721
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021985Orig1s025ltr.pdf
11/7/2013
AP
0
3/18/2014
SLR
38827
026
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021985s026lbl.pdf
3/19/2014
AP
0
3/27/2015
SLR
42338
027
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021985Orig1s027ltr.pdf
4/1/2015
AP
0
3/27/2015
SLR
42386
027
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021985s027lbl.pdf
4/2/2015
AP
0
12/22/2015
SLR
44869
028
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021985Orig1s028ltr.pdf
12/23/2015
AP
0
12/22/2015
SLR
44885
028
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021985s028lbl.pdf
12/28/2015
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