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FDA Drug Application 021703 by BAXTER HLTHCARE

Application Number021703
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
AP010/25/2006N15245000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021703lbl.pdf 10/26/2006
AP010/25/2006N15278000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021703s000ltr.pdf 10/27/2006
AP010/25/2006N19701000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021703s000TOC.cfm 4/22/2008
AP010/10/2008SCF21045003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021703s003ltr.pdf 10/22/2008
AP010/10/2008SCF21180003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021703s003lbl.pdf 11/7/2008
AP04/20/2009SCP22331004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021703s004lbl.pdf 4/28/2009
AP04/13/2012SLR32437008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021703s008ltr.pdf 4/16/2012
AP04/13/2012SLR32444008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021703s008lbl.pdf 4/17/2012
AP06/10/2013SLR36277010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021703Orig1s010ltr.pdf 6/12/2013
AP010/18/2013SCM       
AP012/13/2013SCM       
AP06/17/2015SCM       
AP02/10/2016SCM       
AP012/15/2015SLR44790016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021703Orig1s016,207026Orig1s001ltr.pdf 12/17/2015
AP012/15/2015SLR44799016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021703s016-207026s001lbl.pdf 12/17/2015
AP07/20/2016SLR46577017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021703s017,207026s002lbl.pdf 7/21/2016
AP07/20/2016SLR46594017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021703Orig1s017,207026Orig1s002ltr.pdf 7/22/2016




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