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FDA Drug Application 050817 by BAXTER HLTHCARE

Application Number050817
Application Type New Drug Application
Sponsor ApplicantBAXTER 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
AP08/5/2008N20585000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050817s000ltr.pdf 8/12/2008
AP08/5/2008N20830000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070797.htm 9/19/2008
AP08/5/2008N24389000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050817_cefepime_toc.cfm 12/31/2009
AP08/5/2008N24390000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050817s000_SumR.pdf 12/31/2009
AP06/30/2010SLR25911001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050817s001ltr.pdf 7/2/2010
AP06/30/2010SLR25924001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050817s001lbl.pdf 7/6/2010
AP06/4/2014SLR39449003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050817Orig1s003ltr.pdf 6/5/2014
AP06/4/2014SLR39497003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050817s003lbl.pdf 6/10/2014
AP09/6/2012SLR33684004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050817Orig1s004ltr.pdf 9/10/2012
AP09/6/2012SLR33715004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050817s004lbl.pdf 9/11/2012
AP05/9/2016SLR45900007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050817Orig1s007ltr.pdf 5/10/2016
AP05/9/2016SLR45940007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050817s007lbl.pdf 5/11/2016




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