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FDA Drug Application 203341 by WYETH PHARMS INC

Application Number203341
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/4/2012N33629000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203341lbl.pdf 9/4/2012
AP09/4/2012N33653000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203341Orig1s000ltr.pdf 9/6/2012
AP09/4/2012N33739000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203341_bosulif_toc.cfm 9/13/2012
AP09/4/2012N33740000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022090s000_SumR.pdf 9/13/2012
AP09/30/2013SLR37279001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203341s001lbl.pdf 9/30/2013
AP09/30/2013SLR37298001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203341Orig1s001ltr.pdf 10/1/2013
AP011/25/2014SLR41110002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203341Orig1s002ltr.pdf 11/28/2014
AP011/25/2014SLR41491002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203341s002lbl.pdf 1/5/2015
AP09/22/2015SLR43984003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203341Orig1s003ltr.pdf 9/24/2015
AP09/22/2015SLR44129003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203341s003lbl.pdf 10/6/2015
AP010/12/2015SLR       
AP04/4/2016SLR45589005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203341s005lbl.pdf 4/5/2016
AP04/4/2016SLR45590005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203341Orig1s005ltr.pdf 4/6/2016




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