Back to FDA Applications sponsored by ALCON

FDA Drug Application 016968 by ALCON

Application Number016968
Application Type New Drug Application
Sponsor ApplicantALCON
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
AP09/28/1972N       
AP08/8/1978SCP       
AP06/12/1978SCP       
AP06/12/1978SCF       
AP04/24/1980SCE       
AP04/24/1980SLR       
AP05/16/1983SCF       
AP012/6/1983SCE       
AP08/13/1984SLR       
AP012/14/1989SLR       
AP08/18/1995SE1       
AP06/26/1996SCS       
AP01/14/1997SCS       
AP05/2/1997SCS       
AP04/15/1999SCP       
AP010/18/1999SCP       
AP012/18/2001SCS       
AP011/25/2002SLR3615020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16968slr020ltr.pdf 11/25/2002
AP011/25/2002SLR3616020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16968slr020_Miostat_lbl.pdf 11/25/2002
AP011/10/2004SLR10584022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16968s022ltr.pdf 11/16/2004
AP011/10/2004SLR10600022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16968s022lbl.pdf 11/16/2004
AP02/23/2015SCM       
AP01/21/2016SLR44999029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016968Orig1s029ltr.pdf 1/22/2016
AP01/21/2016SLR45023029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016968s029lbl.pdf 1/26/2016




Back to FDA Applications sponsored by ALCON

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.