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FDA Drug Application 021446 by PF PRISM CV

Application Number021446
Application Type New Drug Application
Sponsor ApplicantPF 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 TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/30/2004N10923000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21446ltr.pdf 1/11/2005
AP012/30/2004N12023000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_LyricaTOC.cfm 7/18/2005
AP012/30/2004N13180000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm 11/30/2005
AP012/30/2004N24011000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152825.pdf 11/19/2009
AP02/17/2006SLR13634002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021446s002,s003lbl.pdf 2/22/2006
AP02/17/2006SLR13693002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021446s002s003ltr.pdf 3/1/2006
AP02/17/2006SLR13694003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021446s002s003ltr.pdf 3/1/2006
AP02/17/2006SLR13635003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021446s002,s003lbl.pdf 2/22/2006
AP010/27/2006SLR15314006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021446s006ltr.pdf 11/6/2006
AP06/21/2007SE116854010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021446s010lbl.pdf 6/27/2007
AP06/21/2007SE116897010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021446s010ltr.pdf 7/5/2007
AP04/23/2009SLR22402013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021446s013,s014ltr.pdf 5/4/2009
AP04/23/2009SLR22526013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf 5/12/2009
AP04/23/2009SLR22527014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf 5/12/2009
AP04/23/2009SLR22403014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021446s013,s014ltr.pdf 5/4/2009
AP01/5/2010SLR24448018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022488s000,021446s018ltr.pdf 1/6/2010
AP01/5/2010SLR24483018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf 1/8/2010
AP010/8/2010SLR26668021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021446s021ltr.pdf 10/19/2010
AP010/8/2010SLR26763021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021446s021lbl.pdf 10/25/2010
AP04/26/2011SLR28630023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf 4/29/2011
AP04/26/2011SLR28643023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf 4/29/2011
AP04/26/2011SLR28644024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf 4/29/2011
AP04/26/2011SLR28631024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf 4/29/2011
AP08/24/2011SLR29878025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s025,022488s004ltr.pdf 8/26/2011
AP08/24/2011SLR29913025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022488-s004-0211446s025lbl.pdf 8/30/2011
AP06/20/2011SLR29363026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s026,022488s005ltr.pdf 6/29/2011
AP06/20/2011SLR29457026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s026,022488s005lbl.pdf 7/7/2011
AP06/20/2012SE132957028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021446s028ltr.pdf 6/21/2012
AP06/20/2012SE132958028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021446s028lbl.pdf 6/21/2012
AP06/20/2012SE132959028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021446s028mg.pdf 6/21/2012
AP06/20/2012SE133078028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021446Orig1s028_lyrica_toc.cfm 7/6/2012
AP06/20/2012SE133079028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021446Orig1s028SumR.pdf 7/6/2012
AP012/23/2013SLR38172029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021446s029,022488s008lbl.pdf 12/24/2013
AP012/23/2013SLR38185029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022488Orig1s008;021446Orig1s029ltr.pdf 12/26/2013
AP03/9/2016SLR45418030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021446Orig1s030,022488Orig1s010ltr.pdf 3/11/2016
AP03/9/2016SLR45441030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf 3/15/2016
AP07/8/2016SCM       




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