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FDA Drug Application 204508 by BAXTER HLTHCARE

Application Number204508
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/3/2013N37367000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204508Orig1s000ltr.pdf 10/4/2013
AP010/3/2013N37388000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204508s000lbl.pdf 10/8/2013
AP010/3/2013N40728000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204508Orig1s000TOC.cfm 10/7/2014
AP010/3/2013N40729000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204508Orig1s000SumR.pdf 10/7/2014
AP06/6/2014SCM       
AP08/20/2014SCM       
AP011/26/2014SCM       
AP02/8/2016SCM       
AP07/20/2016SLR46579005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204508s005lbl.pdf 7/21/2016
AP07/20/2016SLR46592005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204508Orig1s005ltr.pdf 7/22/2016




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