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FDA Drug Application 020931 by PFIZER

Application Number020931
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/1/1999N29656000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM266314.pdf 8/2/2011
AP010/1/1999N3974000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20931ltr.pdf 10/4/1999
AP010/1/1999N3975000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20931lbl.pdf 10/4/1999
AP010/1/1999N3976000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-931_Tikosyn.cfm 4/4/2002
AP010/22/2004SLR       
AP010/18/2007SCM       
AP07/11/2011SLR29509003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020931s003ltr.pdf 7/13/2011
AP012/6/2013SLR37989007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020931Orig1s007ltr.pdf 12/9/2013
AP012/6/2013SLR38011007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020931s007lbl.pdf 12/12/2013
AP07/8/2015S43371009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020931Orig1s009ltr.pdf 7/15/2015
AP011/25/2015S44615010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020931Orig1s010ltr.pdf 11/27/2015
AP03/8/2016SLR45404012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020931Orig1s012,s013ltr.pdf 3/10/2016
AP03/8/2016SLR45434012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020931s012s013lbl.pdf 3/14/2016
AP03/8/2016S45405013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020931Orig1s012,s013ltr.pdf 3/10/2016
AP03/8/2016S45433013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020931s012s013lbl.pdf 3/14/2016




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