Back to FDA Applications sponsored by ALCON RES LTD

FDA Drug Application 203491 by ALCON RES LTD

Application Number203491
Application Type New Drug Application
Sponsor ApplicantALCON RES LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/16/2012N34118000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203491s000lbl.pdf 10/17/2012
AP010/16/2012N34121000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203491Orig1s000ltr.pdf 10/18/2012
AP010/16/2012N35641000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203491_nepafenac_toc.cfm 4/8/2013
AP010/16/2012N35642000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203491Orig1s000SumR.pdf 4/8/2013
AP012/14/2012SLR34692001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203491s001lbl.pdf 12/18/2012
AP012/14/2012SLR34708001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203491Orig1s001ltr.pdf 12/19/2012
AP02/5/2014SCM       
AP02/13/2014SCM       
AP012/9/2013SCM       
AP07/3/2014SCM39779006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203491Orig1s006ltr.pdf 7/8/2014
AP09/28/2015SCM       
AP011/10/2015SCM       




Back to FDA Applications sponsored by ALCON RES LTD

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.