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FDA Drug Application 021864 by WYETH PHARMS INC

Application Number021864
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/22/2007N16597000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021864s000ltr.pdf 5/29/2007
AP05/22/2007N16644000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021864lbl.pdf 5/29/2007
AP05/22/2007N21392000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021864_lybrel_toc.cfm 12/22/2008
AP09/15/2008SLR20847002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021864s002ltr.pdf 9/19/2008
AP09/15/2008SLR20868002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021864s002lbl.pdf 9/19/2008
AP012/31/2015SCM       
AP06/16/2016SLR46363007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021864Orig1s007ltr.pdf 6/21/2016
AP06/16/2016SLR46377007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021864s007lbl.pdf 6/21/2016




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