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FDA Drug Application 022212 by ALCON PHARMS LTD

Application Number022212
Application Type New Drug Application
Sponsor ApplicantALCON PHARMS LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/23/2008N20055000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022212lbl.pdf 6/24/2008
AP06/23/2008N20056000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022212s000ltr.pdf 6/24/2008
AP06/23/2008N20293000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022212s000TOC.cfm 7/25/2008
AP06/23/2008N20294000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022212s000_SumR.pdf 7/25/2008
AP03/20/2009SLR22106001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022212s001ltr.pdf 3/25/2009
AP06/13/2012SE132914003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022212s003ltr.pdf 6/15/2012
AP06/13/2012SE132934003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022212s003lbl.pdf 6/18/2012
AP011/27/2012SCM34478010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022212Orig1s010ltr.pdf 11/28/2012
AP011/27/2012SCM34577010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022212s010lbl.pdf 12/10/2012
AP03/22/2013SE835513011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022212s011lbl.pdf 3/26/2013
AP03/22/2013SE835544011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022212Orig1s011ltr.pdf 3/26/2013
AP05/15/2013SLR36082012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022212Orig1s012ltr.pdf 5/16/2013
AP05/15/2013SLR36108012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022212s012lbl.pdf 5/21/2013
AP04/11/2016SCM       
AP07/29/2016SLR46700016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022212s016lbl.pdf 8/2/2016
AP07/29/2016SLR46708016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022212Orig1s016ltr.pdf 8/2/2016




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