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FDA Drug Application 021845 by PFIZER

Application Number021845
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/3/2005N11756000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021845ltr.pdf 6/7/2005
AP06/3/2005N11762000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021845lbl.pdf 6/7/2005
AP06/3/2005N13195000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021845s000_RevatioTOC.cfm 12/2/2005
AP06/3/2005N39594000   http://www.fda.gov/Drugs/DrugSafety/ucm390876.htm 6/20/2014
AP011/3/2005SLR13101001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021845s001ltr.pdf 11/18/2005
AP07/27/2006SLR14592002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021845s002PI.pdf 8/4/2006
AP07/27/2006SLR14612002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021845s002ltr.pdf 8/4/2006
AP07/19/2006SLR14500003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021845s003_ltr.pdf 7/21/2006
AP012/18/2007SLR18684004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021845s004lbl.pdf 12/27/2007
AP012/18/2007SLR18821004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021845s004ltr.pdf 1/9/2008
AP02/17/2009SLR21867005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021845s005ltr.pdf 2/19/2009
AP02/17/2009SLR21890005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021845s005lbl.pdf 2/20/2009
AP05/7/2009SE122483006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021845s006lbl.pdf 5/11/2009
AP05/7/2009SE122547006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021845s006ltr.pdf 5/13/2009
AP011/19/2010SLR27009007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021845s007,022473s001ltr.pdf 11/22/2010
AP011/19/2010SLR27019007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021845s007,022473s001lbl.pdf 11/26/2010
AP08/30/2012SE833627008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021845s008lbl.pdf 8/31/2012
AP08/30/2012SE833638008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021845Orig1s008ltr.pdf 9/5/2012
AP02/3/2015SCM       
AP03/11/2014SLR38777011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s011,022473Orig1s004,203109Origs002ltr.pdf 3/13/2014
AP03/11/2014SLR38786011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s011,022473s004,0203109s002lbl.pdf 3/13/2014
AP01/31/2014SE838421012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf 2/3/2014
AP01/31/2014SE838444012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf 2/4/2014
AP01/31/2014SLR38422013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf 2/3/2014
AP01/31/2014SLR38445013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf 2/4/2014
AP03/6/2014SLR38717014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s014,022473Orig1s007,203109Orig1s005ltr.pdf 3/7/2014
AP03/6/2014SLR38724014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s014,022473s007,203109s005lbl.pdf 3/7/2014
AP04/27/2015SLR42688016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021845Orig1s016,022473Orig1s010,203109Origs009ltr.pdf 4/29/2015
AP04/27/2015SLR42778016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021845s016,022473s010,203109s009lbl.pdf 5/12/2015




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