Back to FDA Applications sponsored by MONARCH PHARMS

FDA Drug Application 050168 by MONARCH PHARMS

Application Number050168
Application Type New Drug Application
Sponsor ApplicantMONARCH PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/26/1957N       
AP07/6/1983SCM       
AP06/25/1984SLR       
AP09/6/1960SCE       
AP012/4/1985SLR       
AP05/16/1986SLR       
AP04/7/1986SCM       
AP05/24/1962SLR       
AP05/24/1962SLR       
AP09/22/1993SCS       
AP06/1/1962SLR       
AP07/24/1963SLR       
AP010/4/1963SLR       
AP010/17/1963SLR       
AP012/22/1964SLR       
AP01/6/1965SLR       
AP01/11/1965SLR       
AP01/12/1965SLR       
AP03/22/1965SLR       
AP04/6/1965SLR       
AP06/8/1965SLR       
AP05/12/1966SLR       
AP08/26/1966SLR       
AP011/3/1966SLR       
AP01/13/1967SLR       
AP01/20/1967SLR       
AP02/10/1967SLR       
AP03/20/1967SLR       
AP02/24/1967SLR       
AP03/3/1967SLR       
AP03/3/1967SLR       
AP04/6/1967SLR       
AP07/20/1967SLR       
AP07/20/1967SLR       
AP08/11/1967SLR       
AP012/18/1967SLR       
AP07/2/1968SLR       
AP08/14/1968SCS       
AP03/4/1969SCM       
AP07/8/1969SLR       
AP04/7/1970SLR       
AP04/17/1970SLR       
AP08/11/1970SCF       
AP05/25/1970SLR       
AP06/15/1970SLR       
AP07/24/1970SLR       
AP05/23/1973SLR       
AP05/10/1971SCF       
AP06/23/1972SLR       
AP07/5/1972SLR       
AP010/16/1972SLR       
AP010/17/1972SCM       
AP02/12/1974SCM       
AP04/24/1974SLR       
AP06/16/1974SCM       
AP01/13/1977SLR       
AP05/6/1977SCM       
AP06/19/1978SCS       
AP010/20/1981SCM       
AP03/26/1982SCM       
AP07/19/1999SLR       
AP011/4/1998SCS       
AP05/28/1999SCM       
AP08/13/2001SCM       
AP011/21/2003SCS6994078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50168slr078ltr.pdf 11/28/2003
AP011/21/2003SCS7034078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50168slr078_cotisporin_lbl.pdf 12/2/2003




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.