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FDA Drug Application 200179 by BAYER HLTHCARE

Application Number200179
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
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
AP06/17/2010N25760000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200179s000ltr.pdf 6/21/2010
AP06/17/2010N25787000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200179lbl.pdf 6/24/2010
AP06/17/2010N27419000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200179_staxyn_toc.cfm 1/4/2011
AP08/2/2013SE836690001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200179Orig1s001ltr.pdf 8/5/2013
AP08/2/2013SE836706001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200179s001lbl.pdf 8/6/2013
AP04/29/2014SLR39180002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200179Orig1s002ltr.pdf 4/30/2014
AP04/29/2014SLR39209002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200179s002lbl.pdf 5/2/2014
AP09/16/2015SLR43906003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200179Orig1s003ltr.pdf 9/17/2015
AP09/16/2015SLR43952003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200179s003lbl.pdf 9/23/2015




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