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FDA Drug Application 022488 by PF PRISM CV

Application Number022488
Application Type New Drug Application
Sponsor ApplicantPF PRISM CV
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/4/2010N24447000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022488s000,021446s018ltr.pdf 1/6/2010
AP01/4/2010N24480000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152825.pdf 1/8/2010
AP01/4/2010N24484000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022488,021446s018lbl.pdf 1/8/2010
AP01/4/2010N25768000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022488_lyrica_toc.cfm 6/22/2010
AP01/4/2010N25769000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022488s000sumr.pdf 6/22/2010
AP04/26/2011SLR28634001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf 4/29/2011
AP04/26/2011SLR28640001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf 4/29/2011
AP04/26/2011SLR28633002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf 4/29/2011
AP04/26/2011SLR28641002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf 4/29/2011
AP04/26/2011SLR28632003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s023,s024,022488s001,s002,s003ltr.pdf 4/29/2011
AP04/26/2011SLR28642003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003lbl.pdf 4/29/2011
AP08/24/2011SLR29879004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s025,022488s004ltr.pdf 8/26/2011
AP08/24/2011SLR29914004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022488-s004-0211446s025lbl.pdf 8/30/2011
AP06/20/2011SLR29364005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021446s026,022488s005ltr.pdf 6/29/2011
AP06/20/2011SLR29456005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s026,022488s005lbl.pdf 7/7/2011
AP04/16/2012SLR32462006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022488s006ltr.pdf 4/18/2012
AP02/28/2013SE835309007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022488Orig1s007ltr.pdf 3/1/2013
AP02/28/2013SE835471007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022488s007lbl.pdf 3/15/2013
AP012/23/2013SCM38171008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021446s029,022488s008lbl.pdf 12/24/2013
AP012/23/2013SCM38184008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022488Orig1s008;021446Orig1s029ltr.pdf 12/26/2013
AP03/9/2016SLR45419010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021446Orig1s030,022488Orig1s010ltr.pdf 3/11/2016
AP03/9/2016SLR45440010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s030,022488s010lbl.pdf 3/15/2016




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