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FDA Drug Application 050442 by PFIZER

Application Number050442
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/5/1972N       
AP08/3/1989SCS       
AP05/11/1992SLR       
AP012/11/1972SE2       
AP09/3/1976SE2       
AP09/21/1977SE2       
AP010/3/1977SLR       
AP03/7/1978SLR       
AP05/11/1981SLR       
AP06/18/2002SLR2499015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf 6/18/2002
AP09/11/2013SLR37088016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050442Orig1s016ltr.pdf 9/13/2013
AP09/11/2013SLR37123016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050442s016lbl.pdf 9/17/2013
AP09/24/2014SLR40601017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050442Orig1s017ltr.pdf 9/25/2014
AP09/24/2014SLR40629017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050442s017lbl.pdf 9/26/2014
AP03/31/2016SLR45581018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf 4/5/2016
AP03/31/2016SLR45605018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf 4/7/2016




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