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Back to FDA Applications sponsored by PF PRISM CV
FDA Drug Application 021446 by PF PRISM CV
Application Number
021446
Application Type
New Drug Application
Sponsor Applicant
PF PRISM CV
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
12/30/2004
N
10923
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21446ltr.pdf
1/11/2005
AP
0
12/30/2004
N
12023
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_LyricaTOC.cfm
7/18/2005
AP
0
12/30/2004
N
13180
000
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm
11/30/2005
AP
0
12/30/2004
N
24011
000
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152825.pdf
11/19/2009
AP
0
2/17/2006
SLR
13634
002
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021446s002,s003lbl.pdf
2/22/2006
AP
0
2/17/2006
SLR
13693
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021446s002s003ltr.pdf
3/1/2006
AP
0
2/17/2006
SLR
13635
003
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021446s002,s003lbl.pdf
2/22/2006
AP
0
2/17/2006
SLR
13694
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021446s002s003ltr.pdf
3/1/2006
AP
0
10/27/2006
SLR
15314
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021446s006ltr.pdf
11/6/2006
AP
0
6/21/2007
SE1
16854
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021446s010lbl.pdf
6/27/2007
AP
0
6/21/2007
SE1
16897
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021446s010ltr.pdf
7/5/2007
AP
0
4/23/2009
SLR
22402
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021446s013,s014ltr.pdf
5/4/2009
AP
0
4/23/2009
SLR
22526
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf
5/12/2009
AP
0
4/23/2009
SLR
22403
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021446s013,s014ltr.pdf
5/4/2009
AP
0
4/23/2009
SLR
22527
014
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf
5/12/2009
AP
0
1/5/2010
SLR
24448
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022488s000,021446s018ltr.pdf
1/6/2010
AP
0
1/5/2010
SLR
24483
018
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf
1/8/2010
AP
0
10/8/2010
SLR
26668
021
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021446s021ltr.pdf
10/19/2010
AP
0
10/8/2010
SLR
26763
021
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021446s021lbl.pdf
10/25/2010
AP
0
4/26/2011
SLR
28630
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf
4/29/2011
AP
0
4/26/2011
SLR
28643
023
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf
4/29/2011
AP
0
4/26/2011
SLR
28631
024
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf
4/29/2011
AP
0
4/26/2011
SLR
28644
024
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf
4/29/2011
AP
0
8/24/2011
SLR
29878
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s025,022488s004ltr.pdf
8/26/2011
AP
0
8/24/2011
SLR
29913
025
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022488-s004-0211446s025lbl.pdf
8/30/2011
AP
0
6/20/2011
SLR
29363
026
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s026,022488s005ltr.pdf
6/29/2011
AP
0
6/20/2011
SLR
29457
026
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s026,022488s005lbl.pdf
7/7/2011
AP
0
6/20/2012
SE1
32957
028
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021446s028ltr.pdf
6/21/2012
AP
0
6/20/2012
SE1
32958
028
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021446s028lbl.pdf
6/21/2012
AP
0
6/20/2012
SE1
32959
028
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021446s028mg.pdf
6/21/2012
AP
0
6/20/2012
SE1
33078
028
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021446Orig1s028_lyrica_toc.cfm
7/6/2012
AP
0
6/20/2012
SE1
33079
028
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021446Orig1s028SumR.pdf
7/6/2012
AP
0
12/23/2013
SLR
38172
029
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021446s029,022488s008lbl.pdf
12/24/2013
AP
0
12/23/2013
SLR
38185
029
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022488Orig1s008;021446Orig1s029ltr.pdf
12/26/2013
AP
0
3/9/2016
SLR
45418
030
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021446Orig1s030,022488Orig1s010ltr.pdf
3/11/2016
AP
0
3/9/2016
SLR
45441
030
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf
3/15/2016
AP
0
7/8/2016
SCM
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