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FDA Drug Application 021951 by RANBAXY

Application Number021951
Application Type New Drug Application
Sponsor ApplicantRANBAXY
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
AP05/25/2012N32773000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021951s000mg.pdf 5/29/2012
AP05/25/2012N32774000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021951s000lbl.pdf 5/29/2012
AP05/25/2012N32780000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021951s000ltr.pdf 5/30/2012
AP05/25/2012N36144000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021951_absorica_toc.cfm 5/24/2013
AP05/25/2012N36360000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=24 6/21/2013
AP07/30/2014SLR40077001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021951Orig1s001ltr.pdf 7/31/2014
AP07/30/2014SLR40081001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021951s001lbl.pdf 7/31/2014
AP08/15/2014SCM40260003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021951Orig1s003ltr.pdf 8/19/2014
AP08/15/2014SCM40288003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021951s003lbl.pdf 8/20/2014
AP010/20/2014SCM       
AP09/3/2015S43824005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021951Orig1s005ltr.pdf 9/8/2015
AP09/3/2015S43830005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021951s005lbl.pdf 9/8/2015
AP012/23/2015SCM       
AP02/4/2016S45121007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021951Orig1s007ltr.pdf 2/5/2016
AP07/8/2016S46493008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021951Orig1s008ltr.pdf 7/12/2016




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