Back to FDA Applications sponsored by MERCK SHARP DOHME

FDA Drug Application 018741 by MERCK SHARP DOHME

Application Number018741
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
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
AP07/27/1983N       
AP09/29/1986SLR       
AP012/15/1983SLR       
AP011/16/1984SLR       
AP02/22/1985SCP       
AP04/23/1986SCM       
AP05/20/1986SCS       
AP09/12/1986SCM       
AP010/29/1987SCM       
AP011/30/1988SCP       
AP05/24/1989SLR       
AP08/1/1990SCS       
AP011/8/1991SCS       
AP010/7/2005SLR12877016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018741s016ltr.pdf 10/14/2005
AP12/9/2006SLR12877016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018741s016ltr.pdf 10/14/2005
AP010/7/2005SLR12886016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018741s016lbl.pdf 10/14/2005
AP12/9/2006SLR12886016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018741s016lbl.pdf 10/14/2005
AP010/7/2005SLR13621016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s016lbl.pdf 2/22/2006
AP12/9/2006SLR13621016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s016lbl.pdf 2/22/2006
AP010/7/2005SLR13650016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018741s016ltr.pdf 2/22/2006
AP12/9/2006SLR13650016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018741s016ltr.pdf 2/22/2006
AP011/30/1995SCS       
AP06/15/1998SCS       
AP07/31/1998SCS       
AP06/15/1998SCS       
AP011/10/1998SCP       
AP08/28/2006SE514769028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s028lbl.pdf 8/29/2006
AP08/28/2006SE514876028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018741s028LTR.pdf 9/18/2006
AP08/13/2014SLR40237036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,019716s030ltr.pdf 8/14/2014
AP08/13/2014SLR40253036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018741s036lbl.pdf 8/15/2014




Back to FDA Applications sponsored by MERCK SHARP DOHME

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.