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FDA Drug Application 050218 by MONARCH PHARMS

Application Number050218
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
AP04/16/1963N       
AP08/9/1985SLR       
AP08/9/1985SLR       
AP012/4/1985SCP       
AP08/18/1987SCP       
AP04/23/1992SCS       
AP07/24/1963SLR       
AP07/17/1963SLR       
AP07/24/1963SLR       
AP09/4/1963SLR       
AP03/3/1964SLR       
AP05/8/1964SCS       
AP05/8/1964SLR       
AP07/15/1964SLR       
AP01/12/1965SCS       
AP01/28/1965SCE       
AP011/30/1966SCP       
AP07/22/1966SLR       
AP03/20/1967SLR       
AP03/29/1967SCS       
AP05/15/1967SLR       
AP06/19/1967SLR       
AP01/29/1968SLR       
AP03/4/1969SCM       
AP04/25/1969SLR       
AP07/7/1969SLR       
AP05/12/1970SCS       
AP08/11/1970SCM       
AP07/27/1970SLR       
AP08/26/1970SLR       
AP05/11/1971SCF       
AP03/22/1972SLR       
AP06/21/1972SLR       
AP07/25/1972SLR       
AP07/27/1972SLR       
AP010/4/1972SLR       
AP03/8/1974SLR       
AP04/24/1974SLR       
AP05/1/1974SLR       
AP01/13/1977SLR       
AP08/6/1981SCS       
AP03/26/1982SCM       
AP04/27/1982SCP       
AP07/19/1999SLR       
AP011/20/1998SCS       
AP07/13/2000SCM       
AP03/21/2001SCM       
AP012/20/2002SLR8877051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50218slr051ltr.pdf 6/2/2004
AP03/26/2013SCM       




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