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FDA Drug Application 021891 by BAYER HEALTHCARE LLC

Application Number021891
Application Type New Drug Application
Sponsor ApplicantBAYER HEALTHCARE LLC
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
AP08/23/2006N14821000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021891lbl.pdf 9/15/2006
AP08/23/2006N14888000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021891s000ltr.pdf 9/18/2006
AP08/23/2006N20180000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021891s000TOC.cfm 7/9/2008
AP010/21/2008SLR21068004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021891s004ltr.pdf 10/23/2008
AP010/8/2008SCS20982005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021891s005ltr.pdf 10/9/2008
AP03/3/2010N25840008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021891s008ltr.pdf 6/29/2010
AP01/4/2013SCM       
AP03/26/2013SCM       
AP09/10/2013SCM       
AP07/25/2014SLR40017018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021891Orig1s018ltr.pdf 7/28/2014
AP07/25/2014SLR40049018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021891Orig1s018lbl.pdf 7/29/2014
AP09/24/2015SCM       
AP012/23/2015SLR44893020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021891Orig1s020ltr.pdf 12/29/2015
AP012/23/2015SLR45151020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021891Orig1s020lbl.pdf 2/11/2016
AP04/5/2016SLR45598021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021891Orig1s021ltr.pdf 4/7/2016
AP04/5/2016SLR45640021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021891Orig1s021lbl.pdf 4/11/2016




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