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FDA Drug Application 021269 by PFIZER

Application Number021269
Application Type New Drug Application
Sponsor ApplicantPFIZER
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
AP02/22/2005N11165000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021269ltr.pdf 2/23/2005
AP02/22/2005N11175000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021269lbl.pdf 2/23/2005
AP02/22/2005N20916000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021269_carduraxl_toc.cfm 10/2/2008
AP03/24/2006SLR13855001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021269s001ltr.pdf 4/5/2006
AP03/16/2010SLR25046011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021269s011lbl.pdf 3/17/2010
AP03/16/2010SLR25088011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021269s011ltr.pdf 3/22/2010
AP07/8/2011SLR29473012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021269s012ltr.pdf 7/12/2011
AP07/8/2011SLR29489012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021269s012lbl.pdf 7/12/2011
AP011/30/2012SCM       
AP07/28/2014SCM       
AP06/8/2015SLR43031017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021269Orig1s17ltr.pdf 6/10/2015
AP06/8/2015SLR43041017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021269s017lbl.pdf 6/11/2015




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