Back to FDA Applications sponsored by MONARCH PHARMS

FDA Drug Application 018452 by MONARCH PHARMS

Application Number018452
Application Type New Drug Application
Sponsor ApplicantMONARCH PHARMS
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
AP06/23/1981N       
AP09/16/1982SCS       
AP011/1/1984SPD       
AP05/16/1983SCP       
AP06/1/1984SLR       
AP03/14/1986SCM       
AP08/11/1987SLR       
AP011/9/1990SLR       
AP04/22/1987SCS       
AP011/2/1987SCM       
AP03/19/1997SLR       
AP03/19/1997SLR       
AP04/6/1989SCS       
AP07/9/1990SCP       
AP03/19/1997SLR       
AP012/1/1992SCS       
AP08/21/1992SLR       
AP02/22/1993SCM       
AP03/16/1993SCM       
AP09/11/1996SLR       
AP03/19/1997SLR       
AP07/12/1996SCM       
AP02/14/1997SLR       
AP03/11/2008SLR19448025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf 3/13/2008
AP03/11/2008SLR19456025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017376s058, 017598s040, 018452s025ltr.pdf 3/13/2008




Back to FDA Applications sponsored by MONARCH PHARMS

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.