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Back to FDA Applications sponsored by HOFFMANN LA ROCHE
FDA Drug Application 020766 by HOFFMANN LA ROCHE
Application Number
020766
Application Type
New Drug Application
Sponsor Applicant
HOFFMANN LA ROCHE
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
4/23/1999
N
4840
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20766ltr.pdf
4/26/1999
AP
0
4/23/1999
N
4841
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20766lbl.pdf
4/26/1999
AP
0
4/23/1999
N
4842
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020766a.cfm
8/13/1999
AP
0
8/31/1999
SLR
AP
0
4/6/2000
SLR
AP
0
4/6/2000
SLR
AP
0
1/9/2001
SCS
AP
0
1/29/2001
SCP
AP
0
6/25/2001
SLR
5441
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20766s7lbl.pdf
4/23/2001
AP
0
11/12/2001
SCP
17071
009
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020766_S009_XENICAL_CAPS_AP.pdf
7/6/2007
AP
0
12/19/2001
SCS
AP
0
12/19/2001
SCS
AP
0
2/21/2002
SCS
AP
0
3/8/2002
SCM
17070
013
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020766_S013_XENICAL_CAPS_AP.pdf
7/6/2007
AP
0
2/27/2002
SCM
AP
0
12/12/2003
SE5
7279
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20766se5-018ltr.pdf
12/19/2003
AP
0
12/12/2003
SE5
7445
018
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20766se5-018_xenical_lbl.pdf
12/29/2003
AP
0
12/12/2003
SE5
17050
018
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020766_S018_XENICAL_CAPSULES_AP.pdf
7/6/2007
AP
0
10/22/2004
SE8
10483
019
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20766s019ltr.pdf
10/29/2004
AP
0
10/22/2004
SE8
10513
019
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766s019lbl.pdf
11/1/2004
AP
0
10/22/2004
SE8
17074
019
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020766_S019_XENICAL_CAPS_AP.pdf
7/6/2007
AP
0
7/9/2004
SLR
9733
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20766slr020ltr.pdf
7/14/2004
AP
0
7/9/2004
SLR
9740
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766slr020_xenical_lbl.pdf
7/14/2004
AP
0
9/2/2005
SLR
12741
021
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020766s021lbl.pdf
9/8/2005
AP
0
9/2/2005
SLR
12742
021
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020766s021ltr.pdf
9/8/2005
AP
0
9/2/2005
SLR
17073
021
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020766_S021_XENICAL_CAPS_AP.pdf
7/6/2007
AP
0
1/5/2007
SLR
15617
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020766s022lbl.pdf
1/8/2007
AP
0
1/5/2007
SLR
15644
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020766s022_ltr.pdf
1/12/2007
AP
0
2/11/2009
SLR
21809
026
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020766s026lbl.pdf
2/12/2009
AP
0
2/11/2009
SLR
21850
026
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020766s026ltr.pdf
2/18/2009
AP
0
5/25/2010
SLR
25616
028
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020766s028ltr.pdf
5/25/2010
AP
0
5/25/2010
SLR
25617
028
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s028lbl.pdf
5/25/2010
AP
0
1/20/2012
SLR
31501
029
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020766s029lbl.pdf
1/24/2012
AP
0
1/20/2012
SLR
31506
029
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020766s029ltr.pdf
1/25/2012
AP
0
12/17/2010
SCM
27344
030
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s030lbl.pdf
12/22/2010
AP
0
12/17/2010
SCM
27357
030
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020766s030ltr.pdf
12/22/2010
AP
0
4/5/2013
SCM
AP
0
4/2/2013
SCM
AP
0
10/16/2013
SLR
37453
033
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020766Orig1s033ltr.pdf
10/18/2013
AP
0
10/16/2013
SLR
37470
033
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf
10/18/2013
AP
0
4/30/2014
SCM
AP
0
8/7/2015
SLR
43609
035
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020766s035lbl.pdf
8/10/2015
AP
0
8/7/2015
SLR
43615
035
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020766Orig1s035ltr.pdf
8/11/2015
AP
0
8/12/2016
SLR
46775
036
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020766Orig1s036ltr.pdf
8/15/2016
Back to FDA Applications sponsored by HOFFMANN LA ROCHE