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Back to FDA Applications sponsored by VALEANT LUXEMBOURG
FDA Drug Application 021119 by VALEANT LUXEMBOURG
Application Number
021119
Application Type
New Drug Application
Sponsor Applicant
VALEANT LUXEMBOURG
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
4/12/2000
N
1247
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21119ltr.pdf
4/12/2000
AP
0
4/12/2000
N
1248
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21119lbl.pdf
4/12/2000
AP
0
4/12/2000
N
2817
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-119_Visudyne.cfm
4/12/2000
AP
0
8/22/2001
SE1
2814
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21119s1ltr.pdf
8/22/2001
AP
0
8/22/2001
SE1
2815
001
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21119s1lbl.pdf
8/22/2001
AP
0
8/22/2001
SE1
2816
001
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-119S001_Visudyne.cfm
8/22/2001
AP
0
2/15/2002
SCM
AP
0
4/30/2002
SLR
2812
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119s003ltr.pdf
4/30/2002
AP
0
4/30/2002
SLR
2813
003
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s3lbl.pdf
4/30/2002
AP
0
4/30/2002
SLR
11214
003
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-119s003_Visudyne.cfm
3/8/2005
AP
0
5/29/2002
SCM
2810
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119s004ltr.pdf
5/29/2002
AP
0
5/29/2002
SCM
2811
004
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119s4lbl.pdf
5/29/2002
AP
0
5/29/2002
SCM
11213
004
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-119s004_Visudyne.cfm
3/8/2005
AP
0
11/25/2002
SLR
2808
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21119slr005ltr.pdf
12/9/2002
AP
0
11/25/2002
SLR
2809
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21119slr005_visudyne_lbl.pdf
11/25/2002
AP
0
2/12/2004
SLR
7762
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21119slr006,scp010ltr.pdf
3/2/2004
AP
0
2/12/2004
SCP
7763
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21119slr006,scp010ltr.pdf
3/2/2004
AP
0
3/25/2005
SLR
11312
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21119s012ltr.pdf
3/30/2005
AP
0
3/25/2005
SLR
11313
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21119s012lbl.pdf
3/30/2005
AP
0
6/30/2008
SE8
20110
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021119s013lbl.pdf
6/30/2008
AP
0
6/30/2008
SE8
20142
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021119se8-013ltr.pdf
7/1/2008
AP
0
3/28/2007
SLR
16126
021
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021119s021lbl.pdf
3/31/2007
AP
0
3/28/2007
SLR
16179
021
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021119s021ltr.pdf
4/9/2007
AP
0
6/28/2012
SLR
33061
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021119s022lbl.pdf
6/29/2012
AP
0
6/28/2012
SLR
33065
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021119s022ltr.pdf
6/29/2012
AP
0
10/8/2013
SCM
AP
0
5/6/2014
SCM
AP
0
5/11/2016
SLR
46018
027
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021119Orig1s027ltr.pdf
5/12/2016
AP
0
5/11/2016
SLR
46037
027
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021119s027lbl.pdf
5/17/2016
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